MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,MCOL MG,4.7MM,11.5MML; DENTAL IMPLANT

Catalog Number	TSVMWB11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) a2: age at time of the event unknown / not provided.G4: premarket identification k101880.Zimvie received one (1) tsvmwb11, (imp, tsv,mcol mg,4.7mm,11.5mml) for evaluation.Visual evaluation was performed, the implant had signs of use.It was damaged from being trephined.The implant¿s bundled mount was disengaged from the implant; however, it was fractured at the hex.The hex piece was not returned.Dhr review was completed for the subject lot number 1257339.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 1257339 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture : mount¿ the customer did submit images for the reported event.The image was of the implants outer box packaging.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.Implant¿s bundled mount was fractured.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
Doctor reported that the implant could no longer be unscrewed from the lower jaw after it had been screwed in with only half of the thread, the procedure was delayed to remove the implant.Another implant was placed to complete the procedure.Upon review/inspection of returned product.The implant/mount were returned disengaged.However, the bundled mount was fractured at the hex.After follow up with the doctor, he confirmed that the mount fractured during the procedure.

• Brand Name: IMP,TSV,MCOL MG,4.7MM,11.5MML
• 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: 24362519
• Report Number: 0001038806-2026-00780
• Device Sequence Number: 9888109
• Product Code: DZE
• UDI-Device Identifier: 00889024019782
• UDI-Public: (01)00889024019782(17)270814(10)1257339
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 02/17/2026

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: Health Professional
• Device Catalogue Number: TSVMWB11
• Device Lot Number: 1257339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic