MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Catalog Number	OSS485
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.D10: concomitant medical product: boet510, t3® ex hex tapered implant 5 x 10mm, lot: 2022020796.
Event or Problem Description
The doctor reports that the dental implants failed due to allergic reaction & infection.The doctor reports in the per that the procedure was not concluded by placing another implants.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b3: date of event b4: date of this report d1: brand name d4: catalog number d4: lot number updated to unknown d4: expiration date updated to unknown d4: unique identifier (udi) number updated to unknown g3: date received by manufacturer g4: premarket identification g6: type of report h1: type of reportable event h2: follow up type h4: device manufacture date updated to unknown.
Event or Problem Description
No further event information is available at the time of this report.
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) oss485, (osseotite® implant 4 x 8.5mm) for evaluation.Visual evaluation was performed, the reported boet410 implant was not returned.The customer returned an oss485 instead.The returned implant had signs of use.The implant has markings from removal.There was no damage identified or signs of malfunction that would have contributed to the event.Measurements match drawing.Dhr review by lot number could not be performed, as the lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the oss485 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: ¿dental: medical: allergic reaction, dental: medical: infection¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors.For infection: 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.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.Infections is a medical condition and is non-verifiable with all the information.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® IMPLANT 4 X 8.5MM
• 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: 23776862
• Report Number: 0001038806-2025-03752
• Device Sequence Number: 18661973
• Product Code: DZE
• UDI-Device Identifier: 00844868033257
• UDI-Public: (01)00844868033257(17)280104(10)2022120758
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/06/2026

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 Catalogue Number: OSS485
• Device Lot Number: 2022120758
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/05/2025
• 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; Not provided
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/29/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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 IMPLANT SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic