MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM; DENTAL IMPLANT

Catalog Number	TSVWH10
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that after two years, the abutment began to loosen, and he believes this is due to damage to the implant¿s hexagon.The procedure was completed.This report refers to damaged hexagon event.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.D10: concomitant medical product: unknown zimmer abutment, lot: unknown.G4: premarket identification pma/510(k) #: k011028|k013227.
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.D3.Manufacturer email address.G1.Contact office name and email address.G1.Contact office - manufacturer site - email address.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.H10: additional narrative.Zimvie received one (1) tsvwh10, (impl tapered scr-v ha 4.7 mm 4.5mm 10mm) for evaluation.Visual evaluation was performed; the implant has signs of use with debris on its external threads.The implants drive feature was damaged.The implant also had a fractured collar, and a fractured screw was stuck inside.The other portion of the screw was not returned.Additional information was obtained on 31-oct-2025 regarding the inspection findings.The customer confirmed that the fractured collar and broken screw occurred during removal of the implant.Dhr review was completed for the subject lot number 1234370.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 1234370 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 customer error, applying to 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: IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 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: 23388910
• Report Number: 0001038806-2025-02692
• Device Sequence Number: 10047606
• Product Code: DZE
• UDI-Device Identifier: 00889024020092
• UDI-Public: (01)00889024020092(17)250222(10)1234370
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 11/27/2025

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 Expiration Date: 02/22/2025
• Device Catalogue Number: TSVWH10
• Device Lot Number: 1234370
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/01/2025
• 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: 10/27/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic