MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Catalog Number	XIFNT3211
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inflammation (1932); Swelling/ Edema (4577)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided d10: concomitant medical product: xifnt415, osseotite® tapered certain® implant 4 x 15mm, lot: 4120004053 xifnt3213, osseotite® tapered certain® implant 3.25 x 13mm, lot: 2120037557.
Event or Problem Description
It was reported that three implants were removed due to having damaged threads and non-integration.On the day of placement, doctor felt that the spirals didn't seem right.Edema and inflammation were reported as a consequence.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 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: 25776749
• Report Number: 0001038806-2026-03606
• Device Sequence Number: 10752925
• Product Code: DZE
• UDI-Device Identifier: 00844868021933
• UDI-Public: (01)00844868021933(17)300713(10)2120036185
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: XIFNT3211
• Device Lot Number: 2120036185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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: DENTAL IMPLANTS SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic