MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 8.5MM; DENTAL IMPLANT

Model Number	XIITP6585
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that internal hex stripped on implant at site # 14.Implant removed.Additional appointments / implant re-placement: not indicated.As a result of the event no injury to the patient was reported.
Additional Manufacturer Narrative
One osseotite® tapered certain® prevail® implant (xiitp6585) was returned for investigation.Visual evaluation of the as returned product identified that the internal threads/hex were stripped/damaged.Additionally, there was bone residue around the external threads due to usage.Functional testing was not performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The implant had been placed on tooth # 14 (universal) for approximately 2 years.X-ray or picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lot (2018020574) 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.Complaint history review was performed for the reported lot number (2018020574) for similar events (complaint category keywords: damaged drive feature) and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11877357
• Report Number: 0001038806-2021-00903
• Device Sequence Number: 3589527
• Product Code: DZE
• UDI-Device Identifier: 00844868022244
• UDI-Public: (01)00844868022244(17)230219(10)2018020574
• 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: 2019
• Device Explanted Year: 2021
• 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): 09/17/2021

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: Health Professional
• Device Expiration Date: 02/19/2023
• Device Model Number: XIITP6585
• Device Catalogue Number: XIITP6585
• Device Lot Number: 2018020574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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