MAUDE Adverse Event Report: BIOMET 3I 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 6 X 11.5MM; DENTAL IMPLANT

Model Number	BOST611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Numbness (2415); Paresthesia (4421)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed due to the patient noting numbness and nerve injury.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One 3i t3® non-platform switched tapered implant 6 x 11.5mm (bost611) was returned for investigation.Visual evaluation of the as returned product identified signs of use but no apparent signs of malfunction.The device could not be functionally tested for the reported failure/event (medical: other ¿ numbness/nerve injury/paresthesia).However, dimensional analysis has confirmed that the product was within specification when it left zimvie.Pre-existing condition noted in the per was high bone density ¿type i.The reported device had been placed on tooth #19 for approximately 1 month.X-ray & picture evaluation: none provided.Appropriate documentation was reviewed.Dhr review for the lot (2020120541) 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.Sterilization record (op#0210) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2020120541) for similar events and no other complaint was identified.November post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur, and the reported event could not be verified as the exact details of event and patient anatomical conditions were unknown/unverifiable.

• Brand Name: 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 6 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15385703
• Report Number: 0001038806-2022-01393
• Device Sequence Number: 17594824
• Product Code: DZE
• UDI-Device Identifier: 00844868029717
• UDI-Public: (01)00844868029717(17)260114(10)2020120541
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: Health Professional
• Device Expiration Date: 01/14/2026
• Device Model Number: BOST611
• Device Catalogue Number: BOST611
• Device Lot Number: 2020120541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female