MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ PREVAIL¿ IMPLANT 6/5 X 15MM; DENTAL IMPLANT

Model Number	XIITP6515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented to office stating implant placed causing ringing in his ears.Removed and grafted patient will return in 6 months for cbct.Tooth 8.Symptoms as a result of the event: other: ringing in his ears.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One osseotite tapered certain prevail implant 6/5 x 15mm (xiitp6515) was returned for investigation.Visual evaluation of the as returned implant identified signs of use but no apparent signs of malfunction.The device could not be functionally tested for the reported failure/medical event.Measurements were taken and the device was determined to be within specification.No pre-existing conditions were noted in the per.The reported device had been placed on tooth # 8 (universal) for approximately 1 week.X-ray or picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lot (2020071270) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event after implantation of the device.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.All sterilization activities were conducted with no nonconformities per sterilization record (op#0210).Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review was performed for the reported lot number (2020071270) for similar events and no other complaint was identified.October 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.The reported event could not be verified as the exact details of event and patient physiological/anatomical conditions were unverifiable.

• Brand Name: OSSEOTITE¿ TAPERED CERTAIN¿ PREVAIL¿ IMPLANT 6/5 X 15MM
• 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: 15699176
• Report Number: 0001038806-2022-01655
• Device Sequence Number: 8229381
• Product Code: DZE
• UDI-Device Identifier: 00844868022237
• UDI-Public: (01)00844868022237(17)250914(10)2020071270
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 09/14/2025
• Device Model Number: XIITP6515
• Device Catalogue Number: XIITP6515
• Device Lot Number: 2020071270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male