MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	IOSS413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight: not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
It was reported that implant (ioss413) was removed due to infection at tooth location 6.Doctor decided to remove the implant as patient had a previous condition prior to the implant placement.Pain was also reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One osseotite® certain® implant (ioss413) was returned for investigation.Visual evaluation of the as returned products identified signs of wear (damage) and bone residue around the external threads and platform of the implant, possibly due to removal procedure.Dhr review for the lot (2018040665) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.All sterilization activities were conducted with no nonconformities per sterilization record.Complaint history review was performed for the reported lot (2018040665) for similar event and one other complaint was found.November post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information, implant signs of wear (damage) was identified possibly due to removal process.However, infection could not be verified as the exact details of event and patient anatomical conditions were nonverifiable.No further investigation or immediate capa, hhe, d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: OSSEOTITE CERTAIN IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10708584
• Report Number: 0001038806-2020-01602
• Device Sequence Number: 3570458
• Product Code: DZE
• UDI-Device Identifier: 00844868007104
• UDI-Public: (01)00844868007104(17)230426(10)2018040665(241)IOSS413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 04/26/2023
• Device Model Number: IOSS413
• Device Catalogue Number: IOSS413
• Device Lot Number: 2018040665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 01/29/2021
• 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: 65 YR