MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP TM 4.7MM MTX FULL, 10; DENTAL IMPLANT

Catalog Number	TMTWB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Product evaluation showed that the bundled mount was fractured at the hex.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) g4: additional pma/510(k) number k113753, k112160.
Additional Manufacturer Narrative
Zimvie received the bundled mount for one (1) tmtwb10, (imp tm 4.7mm mtx full, 10) for evaluation.Visual evaluation was performed; the implant was not returned with its bundled mount.The returned envelope had a hole in it.The unknown screw stuck inside the implant could not be verified.There was a hole in the envelope and sterile peel pack.The returned mount was fractured at the hex and had a fractured piece of a driver stuck inside the mount.Dhr review was completed for the subject lot number 1296528.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 1296528 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 screw fracture malfunction could not be verified.The implant was not returned for evaluation.However, the bundled mount was fractured at the hex.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP TM 4.7MM MTX FULL, 10
• 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: 24283213
• Report Number: 0001038806-2026-00608
• Device Sequence Number: 18215157
• Product Code: DZE
• UDI-Device Identifier: 00889024019034
• UDI-Public: (01)00889024019034(17)300317(10)1296528
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: TMTWB10
• Device Lot Number: 1296528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• 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: 02/06/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic