MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 11.5MM; DENTAL IMPLANT

Catalog Number	XIITP4311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for evaluation of their crown that broke off of the the implant at tooth site #20.The implant was removed due to infection.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / 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
Upon follow up, additional information was received updating this event.The implant was removed due to a screw fracture which caused gum tissue overgrowth over the implant and implant removal.Updated event description: it was reported that the patient returned to the clinic for the uncover of the implant at tooth site #20.The patient stated that the crown broke off and gum tissue grew over the implant.Mainly the retention screw fractured off into the implant requiring implant removal.Based on this new information, the implant was removed due to the screw fracture, not infection.Therefore, this report is being submitted to retract the initial report for the implant, mfr report number that was submitted on january 7, 2026 and has been submitted via the screw under mfr report number 0001038806-2026-00187 that was submitted on january 12, 2026.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: new information was received updating the event description indicating that the implant was removed due to the screw fracture, not infection.This report is being submitted to retract the initial report for the implant, mfr report number that was submitted on january 7, 2026 and has been submitted via the screw under mfr report number 0001038806-2026-00187 that was submitted on january 12, 2026.All details and information regarding this event will be documented and processed under mfr report number 0001038806-2026-00187 and no additional reports will be submitted under mfr report number.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23989959
• Report Number: 0001038806-2026-00089
• Device Sequence Number: 10536235
• Product Code: DZE
• UDI-Device Identifier: 00844868022121
• UDI-Public: (01)00844868022121(17)240125(10)2019010991
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: Other
• Device Expiration Date: 01/25/2024
• Device Catalogue Number: XIITP4311
• Device Lot Number: 2019010991
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DENTAL SCREW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic