MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP, TSV, 4.7, 10, MTXF, MG,HA; DENTAL IMPLANT

Catalog Number	TSVTWH10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant at tooth site #19 had a fractured transfer coping.Unable to separate transfer coping from implant.Hex on transfer coping sheared off in implant (not saved with implant).Procedure completed using another implant 4.7 x 10 mm zimmer tsv.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number k133339.
Additional Manufacturer Narrative
Zimvie received one (1) tsvtwh10, (imp, tsv, 4.7, 10, mtxf, mg,ha) for evaluation.Visual evaluation was performed, the implant shows signs of use.Bone debris observed on its external threads.The fractured mount or impression post was not returned for assessment.The implant's drive feature was damaged, likely due to the removal process.Dhr review was completed for the subject lot number 1286561.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 1286561 for similar events and no other complaint was identified.The customer did not submit images for the reported event.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 could not be verified.The bundled mount was not returned with the implant.The reported event 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.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H11: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.7, 10, MTXF, MG,HA
• 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: 24545859
• Report Number: 0001038806-2026-01237
• Device Sequence Number: 13132971
• Product Code: DZE
• UDI-Device Identifier: 00889024344341
• UDI-Public: (01)00889024344341(17)291010(10)1286561
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101880
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: TSVTWH10
• Device Lot Number: 1286561
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic