MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Model Number	IFNT3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Event date: not provided.Initial reporter fax number: not provided.A summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that implant was removed due to extensive bone loss at tooth location 23.
Additional Manufacturer Narrative
Device was returned to the manufacturer for investigation.Additional information below.Dhr reviews were completed for the subject lot numbers (2016060814).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history reviews were performed for the reported lot numbers (2016060814) for similar events and no other complaint was identified.As documented in the summary investigation, contributing factors for the reported event likely exist outside of zimmer biomet control, including those related to medical conditions / patient habits and surgical technique.Based on the summary investigation, no malfunction occurred upon investigation and no association between the dental implant and bone loss was found that can explain these events.Therefore, the reported event remains non-verifiable as it is a medical condition.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.With no signals indicating a systemic quality issue, no escalation to capa is required.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H6: update evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11279994
• Report Number: 0001038806-2021-00172
• Device Sequence Number: 19505194
• Product Code: DZE
• UDI-Device Identifier: 00844868004950
• UDI-Public: (01)00844868004950(17)210621(10)2016060814(241)IFNT3210
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/21/2021
• Device Model Number: IFNT3210
• Device Catalogue Number: IFNT3210
• Device Lot Number: 2016060814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 46