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

Catalog Number	FNT485
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mount did not disengage the implant.There was no impact on the patient reported.Procedure was completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
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) fnt485, (full osseotite® tapered implant 4 x 8.5mm) for evaluation.Visual evaluation and a functional test were performed, the implant has signs of use with debris on its internal and external threads.The mount disengaged from the implant as intended.Dhr review was completed for the subject lot number 2022100586.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 2022100586 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : does not disengage/release¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error ¿ excessive torque used to place implant cover screw.Therefore, based on the available information, a device malfunction could not be verified.The mount disengaged from the implant.The reported event for the stuck mount was non-verifiable.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: FULL OSSEOTITE TAPERED 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: 23554330
• Report Number: 0001038806-2025-03150
• Device Sequence Number: 10132808
• Product Code: DZE
• UDI-Device Identifier: 00844868003366
• UDI-Public: (01)00844868003366(17)271024(10)2022100586
• 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: 2024
• Device Explanted Year: 2024
• 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): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: FNT485
• Device Lot Number: 2022100586
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/21/2025
• 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
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic