MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Catalog Number	INT511
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that the implant at tooth site 14, which was part of a bridge over positions 14 and 16, failed due to peri-implantitis and is also fractured in the head, and therefore was removed.The procedure was not completed.Pain was reported as a result of the event.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event: unknown / not provided.A3: gender: unknown / not provided.A4: patient weight: unknown / not provided.E1: reporter name: unknown / not provided.E1: address-line 2: (b)(6).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H11: additional narrative.Zimvie received one (1) int511, (osseotite® tapered certain® implant 5 x 11.5mm) for evaluation.Visual evaluation was performed, implant shows signs of usage with debris and blood, however no damage/fracture identified.Dhr review was completed for the subject lot number 2120010027.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120010027 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture : implant¿ and ¿functional : peri-implantitis¿ a definitive root cause could not be determined since the device malfunction did not occur, and the reported event has been unconfirmed following physical evaluation.Investigation for ¿ peri-implantitis¿.A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.Therefore, based on the available information, a device malfunction could not be verified for peri-implantitis and malfunction did not occur with fracture.No fracture was identified on implant.The reported event was not confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 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: 24617333
• Report Number: 0001038806-2026-01440
• Device Sequence Number: 15846884
• Product Code: DZE
• UDI-Device Identifier: 00844868006701
• UDI-Public: (01)00844868006701(17)290320(10)2120010027
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: Other
• Device Catalogue Number: INT511
• Device Lot Number: 2120010027
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic