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For Office Use Only Not to be Completed by the Reporter CMP#: Aware Date: Replacement Order #: PRODUCT EXPERIENCE REPORT Note: This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable. Completion of this form does not constitute an admission that medical personnel, distributor, manufacturer, or product caused or contributed to the event. Form # M05.01.01.01 Rev 22 Page 1 of 5 The inclusion of as many details as possible greatly aids the investigation process as well as provides useful information for continuous improvement. Additionally, it is needed to comply with Medical Device Manufacturer Regulatory Requirements. Missing information will delay processing. Required fields are denoted in bold italics. A. REPORTER INFORMATION Complaint # Person Submitting this Report: Date of Report: Is the person submitting this report a: Clinician Lab Distributor Account Name: Account #: Address: Doctor: City, State, Zip, Country: Phone #: Fax: e-mail: Sales Rep: Phone #: Customer requesting a final report? Yes No B. PRODUCT INFORMATION: One form should be used per complaint and/or patient. If more than one device is associated with a single event being reported, multiple Item numbers may be included below. Item Number Lot / Serial # Qty. Is Product Being Returned? If No, Why? (i.e. retained by the hospital, scrapped, etc.) Has product been decontaminated? Requested Replacement Item Number For Patient Specific Product, check if remake requested. Yes No Unk Yes No Unk Remake Yes No Unk Yes No Unk Remake Yes No Unk Yes No Unk Remake Yes No Unk Yes No Unk Remake Yes No Unk Yes No Unk Remake I hereby certify that the above listed product has been decontaminated as stated above: (Sign/Date) __________________________ Method of decontamination: Autoclave Other (Specify): Is destructive analysis permitted? Yes No Are radiographs available? Yes No C. EVENT INFORMATION Placement Date: (dd/mmm/yyyy) Event Date: (dd/mmm/yyyy) Removal Date: (dd/mmm/yyyy) Description of the Event (Check all that apply) Non-Integration (NI) Loss of Integration (LI) Cosmetic Fit Fracture Malfunction Other: Discovered: During receiving / unpacking During clinical procedure During Laboratory Procedure Other: Provide a detailed description of the reported problem (including procedure being performed, related products and settings used): __________________________________________________________________________________________________ Was there any injury to the patient as a result of the event? Yes No If Yes, please describe: Was surgical intervention necessary to preclude permanent impairment? Yes No If Yes, please describe: Will the patient have to return for an additional dental appointment to complete the procedure? If yes, explain: Was there a delay in the surgical procedure? Yes No If Yes, what was the duration of the delay?

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Page 1: M05.01.01.01 Rev 22 Product Experience Report …biomet3i.com/PDF/ComplaintReport.pdf · µ u v , ] P Z ~ o v W d } } ^ Z } ~> P o v d } } d o o ~^ u o o o v

For Office Use Only Not to be Completed by the Reporter

CMP#:

Aware Date:

Replacement Order #:

PRODUCT EXPERIENCE REPORT

Note: This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable. Completion of this form does not constitute an admission that medical personnel, distributor, manufacturer, or product caused or contributed to the event.

Form # M05.01.01.01 Rev 22 Page 1 of 5

The inclusion of as many details as possible greatly aids the investigation process as well as provides useful information for continuous improvement. Additionally, it is needed to comply with Medical Device Manufacturer Regulatory Requirements. Missing information will delay processing. Required fields are denoted in bold italics. A. REPORTER INFORMATION

Complaint # Person Submitting this Report: Date of Report: Is the person submitting this report a: Clinician Lab Distributor Account Name: Account #: Address: Doctor: City, State, Zip, Country: Phone #: Fax: e-mail: Sales Rep: Phone #: Customer requesting a final report? Yes No

B. PRODUCT INFORMATION: One form should be used per complaint and/or patient. If more than one device is associated with a single event being reported, multiple Item numbers may be included below.

Item Number Lot / Serial # Qty. Is Product Being

Returned?

If No, Why? (i.e. retained by the

hospital, scrapped, etc.)

Has product been decontaminated?

Requested Replacement Item Number

For Patient Specific Product, check if remake requested.

Yes No Unk Yes No Unk Remake

Yes No Unk Yes No Unk Remake

Yes No Unk Yes No Unk Remake

Yes No Unk Yes No Unk Remake

Yes No Unk Yes No Unk Remake

I hereby certify that the above listed product has been decontaminated as stated above: (Sign/Date) __________________________ Method of decontamination: Autoclave Other (Specify): Is destructive analysis permitted? Yes No Are radiographs available? Yes No

C. EVENT INFORMATION Placement Date: (dd/mmm/yyyy)

Event Date: (dd/mmm/yyyy)

Removal Date: (dd/mmm/yyyy)

Description of the Event (Check all that apply) Non-Integration (NI) Loss of Integration (LI) Cosmetic Fit Fracture Malfunction Other:

Discovered: During receiving / unpacking During clinical procedure During Laboratory Procedure Other:

Provide a detailed description of the reported problem (including procedure being performed, related products and settings used): __________________________________________________________________________________________________ Was there any injury to the patient as a result of the event? Yes No If Yes, please describe: Was surgical intervention necessary to preclude permanent impairment? Yes No If Yes, please describe: Will the patient have to return for an additional dental appointment to complete the procedure? If yes, explain: Was there a delay in the surgical procedure? Yes No If Yes, what was the duration of the delay?

Page 2: M05.01.01.01 Rev 22 Product Experience Report …biomet3i.com/PDF/ComplaintReport.pdf · µ u v , ] P Z ~ o v W d } } ^ Z } ~> P o v d } } d o o ~^ u o o o v

Note: This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable. Completion of this form does not constitute an admission that medical personnel, distributor, manufacturer, or product caused or contributed to the event.

Form # M05.01.01.01 Rev 22 Page 2 of 5

Describe what happened to the patient as a result of the event (Check all that apply):

No Patient Impact

Allergic Reaction Aspiration Bone Loss Dehiscence Delayed Healing Edema

Hemorrhage Hyperesthesia Hyperplasia Infection Inflammation Ingestion

Nerve Damage Pain Paresthesia Other:

Other Relevant Patient History (Check all that apply):

Smoker / Tobacco use Oral Hygiene:

Bruxism Osteoporosis

Clenching Diabetes Other

Additional Information: Site Grafted If Yes, Describe Material

Autogenous Allograft Xenograft

Alloplast Hybrid

Was the implant restored (provisional or final)? Yes No N/A If Yes, please check one: Immediate (within 48 hrs) Early (within 8 wks) Traditional (3-4 mos mandible, 4-6 mos maxilla)

D. PATIENT INFORMATION Patient Identifier: Gender: Male Female Age at the time of the event: Weight: lbs kgs Unk Tooth Number: Dental Notation Systems: Universal FDI Palmer Bone Density Type: I II III IV Unk Patient’s Condition at the time of the event:

E. PATIENT SPECIFIC PRODUCT ONLY BellaTek™ or ZFx™ Abutment: Was the abutment designed: By the lab By BellaTek™ or ZFx™ designer Was the Impression taken: Implant Level Encode Intra Oral Scan Do you know if a radiograph was taken to ensure Encode healing abutments were completely seated at time of impression? Yes No Unknown Was the case remounted by BellaTek™ or ZFx™ technicians? Yes No Was the Analog Placed: At the Lab Robocast by BellaTek™ or ZFx™

If placed with Robocast, is tooth position correct? Yes No Do you know if the Dr. cleared bone or tissue away from the platform of the implant? Yes No Unknown Was the abutment tried into the patient’s mouth or on the model? Model Patient – if Patient is selected, please answer the following questions:

• Was the abutment inserted into the patient’s mouth? Yes No If yes, provide the following: Restorative Dr’s. Name Phone Number • Was the abutment seated in the patient’s mouth? Yes No

If yes, provide the following: Placement Date of Restoration Removal Date of Restoration If Abutment was not as requested, please indicate all that apply: Abutment Seating /Fit: Was the abutment seated?

Yes Was abutment rotated? Yes No Unknown When placing the abutment was the identification marker facing the buccal? Yes No Unknown Was the abutment fit: Too Tight Too Loose Wrong Connection

No

Was the abutment rotated? Yes No Unknown When placing the abutment was the identification marker facing the buccal? Yes No Unknown Is the hex engaged? Yes No Is there bone or tissue interference? Buccal Lingual Mesial Distal Unknown

Abutment Height (Clearance): Too Short (Large Clearance) Too Tall (Small Clearance) Angulation:

Page 3: M05.01.01.01 Rev 22 Product Experience Report …biomet3i.com/PDF/ComplaintReport.pdf · µ u v , ] P Z ~ o v W d } } ^ Z } ~> P o v d } } d o o ~^ u o o o v

Note: This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable. Completion of this form does not constitute an admission that medical personnel, distributor, manufacturer, or product caused or contributed to the event.

Form # M05.01.01.01 Rev 22 Page 3 of 5

Incorrect alignment with adjacent teeth Yes No Multi-Units: Not Parallel Yes No Direction of incorrect orientation Buccal Lingual Mesial Distal

Missing Design Feature? Yes Describe: No

Abutment Seating /Fit: Continued Margin: Multi-unit / Single-unit: At placement was the identification marker facing the buccal? Yes No Unk Margin: Style Not as requested –rec’d: Chamfer Shoulder Feather Margin: Geometry Shape not as requested –rec’d: Anterior Premolar Molar Margin: Other Sharp Edges Under Cuts

Margin –Depth Buccal: Too low Too High Lingual: Too low Too High Mesial: Too low Too High Distal: Too low Too High

Margin –Tissue Displacement Buccal: Less than desired More than desired Lingual: Less than desired More than desired Mesial: Less than desired More than desired Distal: Less than desired More than desired

Zirconia Fracture? Yes No, If “Yes”, complete the following: What torque device was utilized? Were recommended driver / driver tips utilized? (New driver/driver tips have a laser-marked dot next to the part

number) Yes No Unknown Do you know what the abutment was torqued to? Ncm Was desired Material received? Yes No, if no please complete the following: Material Desired Zirconia Nitride Titanium Material Received Zirconia Nitride Titanium Wrong Platform Size? Yes No What size was Received? What size was desired? Describe the Abutment Appearance: Other issue not described above:

BellaTek™ or ZFx™ Bars: BellaTek™ or ZFx™ Coping: Was the bar tried into the patient’s mouth? Yes No If Yes, please provide: Restorative Dr’s. Name: Phone Number: Was the Bar Fractured? Yes No If yes, state the fracture location: Did the bar fit:

the Patient? Yes No the Model? Yes No

Was the Cast Verified? Yes No Did you make a verification index? Yes No Did the verification index fit the patient? Yes No

Was the coping tried into the patient’s mouth? Yes No If yes, Placement Date of Coping: Removal Date of Coping: If coping was inserted into the patient’s mouth, please provide: Restorative Dr’s. Name: Phone Number: Were you able to seat the coping:

in the patient’s mouth? Yes No on the model? Yes No

If Abutment / Coping was not as requested, please indicate all that apply: MARGIN: Too High Too low Open FIT: Too Tight Too Loose Coping Height: Too High Too low Contact: Open Too Tight Fracture: Yes No Other issue not described above:

Page 4: M05.01.01.01 Rev 22 Product Experience Report …biomet3i.com/PDF/ComplaintReport.pdf · µ u v , ] P Z ~ o v W d } } ^ Z } ~> P o v d } } d o o ~^ u o o o v

Note: This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable. Completion of this form does not constitute an admission that medical personnel, distributor, manufacturer, or product caused or contributed to the event.

Form # M05.01.01.01 Rev 22 Page 4 of 5

Instructions:

Do not return product without Complaint #. Please call your Customer Service Representative to obtain this number prior to shipping complaint product.

When returning product the following guidelines must be followed: 1. Used product MUST be sterilized in pouches which show sterility with color change or other indication

prior to shipping. Metal items must be autoclaved; plastic items must be cold sterilized. 2. For non-Patient Specific Products, return only the complaint product. 3. To ensure product identification and traceability the following information must be provided:

o Primary Package: Each returned component or product has to be individually placed into a primary package labeled with the product description and Complaint #.

o Secondary Package: The primary package is then placed in a secondary package labeled with the contact information (account # is suffice) with any additional components or product to be returned.

4. Include a copy of the Complaint Report and Complaint #. Due to regulatory requirements, please submit this form and the product to the below listed locations immediately after

the event occurred.

Send the complaint product to: US Canada Chile International (APAC & Non-European): Biomet 3i & Zimmer Dental Email: [email protected] Attn: Complaints Handling 4555 Riverside Drive Palm Beach Gardens, FL 33410 Phone: 1.800.443.8166

Biomet 3i & Zimmer Dental Zimmer Dental Corp. 2323 Argentia Road Mississauga, Ontario L5N 5N3 Phone: 514-956-9843

Zimmer Dental Zimmer Dental Chile SPA Luis Thayer Ojeda 0130 Oficina 901/902 Providencia Santiago, Chile

Biomet 3i Email: [email protected] Biomet 3i Attn: Complaints Handling 4555 Riverside Drive Palm Beach Gardens, FL 33410 Phone: 561.776.6918

China Zimmer Dental Zimmer Dental 1003 Fosun International Center 273 North Chao Yang Road, Chao Yang District Beijing 100020 China

Australia: Phone: +61 2 9855 4444 Mexico: Phone: +52 55 2282 0120

Europe Non- Patient Specific Product

Austria: Biomet 3i Zimmer Dental GmbH Zweigniederlassung Österreich Breitwies 1 5303 Thalgau Phone: +43 (0) 8000 700 17 Fax: +43 (0) 8000 700 18

Belgium: Biomet 3i Biomet 3i TAV: Customer Service Prins Boudewijnlaan 24C 2550 Kontich Belgium Phone: +32 80050311

France: Biomet 3i Biomet 3i 7-9 Rue Paul Vaillant Couturier 92300 LeVallois Perret Phone: +33 (0) 141.05.43.43 Zimmer Dental Zimmer Dental SAS 2 place Gustave Eiffel-BP40237 94528 Rungis Cedex

Germany: Biomet 3i & Zimmer Dental Zimmer Dental GmbH Wilhelm-Wagenfeld-Straße 28 80807 München Phone: +49 (0) 800 101 6420 Fax: +49 (0)800 313 11 11

10BEurope

Page 5: M05.01.01.01 Rev 22 Product Experience Report …biomet3i.com/PDF/ComplaintReport.pdf · µ u v , ] P Z ~ o v W d } } ^ Z } ~> P o v d } } d o o ~^ u o o o v

Note: This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable. Completion of this form does not constitute an admission that medical personnel, distributor, manufacturer, or product caused or contributed to the event.

Form # M05.01.01.01 Rev 22 Page 5 of 5

Israel Zimmer Dental Zimmer Dental Ltd 13 Amal St. Rosh A’ain Building A, 3rd Floor Ramat Gan 52523 Israel

Italy Zimmer Dental Zimmer Dental Italy srl Viale Italia 205/D 31015 Conegliano (TV) +39 0438 37681 [email protected] Biomet 3i (Biomax) BIOMAX SPA Via Zamenhof, 615 Vicenza TEL: +39 0444 913 410 E-MAIL: [email protected]

Netherlands: Biomet 3i Biomet 3i Netherlands TAV: Customer Service Toermalijnring 600 3316 LC Dordrecht Phone: +31 078 62 92 800

Spain and Potugal: Biomet 3i and Zimmer Dental Email: [email protected] Biomet 3i Dental Ibérica, S.L. WTC Almeda Park, Ed.4, Planta 2 C/Tirso de Molina, 40 08940 Cornellà de LLobregat (Barcelona) Spain Spain Phone: 900 800 303 Portugal Phone: 800 827 836

Switzerland: BIOMET 3i Schweiz GmbH Grüzefeldstrasse 41 CH-8404 Winterthur Phone: +41 (0)800 24 66 38 Fax: +41 (0)800 24 66 39

UK and Ireland: Biomet 3i

Biomet 3i UK 1 Bell Street Maidenhead Berkshire, UK SL6 1BU UK: Phone: +44 (0) 800 652 1233 Ireland: Phone: +353 1800 552752

Patient Specific – Product Email: [email protected] Address: Biomet 3i Dental Ibérica BellaTek Dept. Islas Baleares 50, Polígono Fuente del Jarro 46988 Valencia Tel.: +34 961379536 / 38 / 05


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