MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,MCOL MG,3.7MM,11.5MML; DENTAL IMPLANT

Catalog Number	TSVMB11
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.
Event or Problem Description
It was reported that implant was removed due to damaged threads.Another implant was placed during the same procedure.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) tsvmb11, (imp,tsv,mcol mg,3.7mm,11.5mml) for evaluation.Visual evaluation was performed, the implant has signs of use with debris attached to its internal and external threads.A bundled cover screw was attached.No damage was identified.Unable to detect any damage with the implants drive feature.Dhr review was completed for the subject lot number 1290469.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 1290469 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿ a definitive root cause could not be determined since device malfunction did not occur.The reported event was unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.No damage was identified with the implant.The reported event was not unconfirmed.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 is available at the time of this report.

• Brand Name: IMP,TSV,MCOL MG,3.7MM,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: 23920526
• Report Number: 0001038806-2025-04122
• Device Sequence Number: 9013176
• Product Code: DZE
• UDI-Device Identifier: 00889024019737
• UDI-Public: (01)00889024019737(17)300121(10)1290469
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 03/09/2026

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: TSVMB11
• Device Lot Number: 1290469
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/17/2025
• 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: 12/30/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic