MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM; DENTAL IMPLANT

Catalog Number	BOST510
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A2: age at time of the event: unknown / not provided.A4: patient weight: unknown / not provided.B3: date of event: unknown / not provided.D1: brand name unknown / provided.D4: additional device information unknown / not provided.D6: d6a.If implanted, give date: 2023.G4: premarket identification pma/510(k) #: unknown / not provided.H4: device manufacturer date: unknown / not provided.
Event or Problem Description
It was reported that the implant was removed due to hex damaged.They placed another implant during the same procedure.
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: b3: date of event.B4: date of this report.B5: describe event or problem.D1: brand name.D4: additional device information.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.H10: additional narrative.
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) bost510, (t3® non-platform switched tapered implant 5 x 10mm) for evaluation.Visual evaluation was performed, the implant has signs of use with bone attached to its external threads the implants drive was damaged from use.The implants has a portion of a fractured screw stuck inside.Dhr review was completed for the subject lot number 2120022300.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 2120022300 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: damaged drive feature¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was applying too much torque/speed during seating.Therefore, based on the available information, a device malfunction did occur.The implants drive feature was damaged.The reported event was 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.

• Brand Name: T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM
• 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: 23861920
• Report Number: 0001038806-2025-04060
• Device Sequence Number: 21153663
• Product Code: DZE
• UDI-Device Identifier: 00844868029656
• UDI-Public: (01)00844868029656(17)291114(10)2120022300
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: Yes
• Operator of Device: Other
• Device Catalogue Number: BOST510
• Device Lot Number: 2120022300
• 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: 12/22/2025
• Supplement Report FDA Received Date: 01/27/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic