MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,4.1MM,SBM,11.5; DENTAL IMPLANT

Catalog Number	TSV4B11
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the screw from the mount/transfer couldn't be removed from the implant and the implant was removed.Proceeding was completed with another product.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).

• Brand Name: IMP,TSV,4.1MM,SBM,11.5
• 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: 24814837
• Report Number: 0001038806-2026-01876
• Device Sequence Number: 21221417
• Product Code: DZE
• UDI-Device Identifier: 00889024019232
• UDI-Public: (01)00889024019232(17)300922(10)1301556
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072589
• 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): 05/21/2026

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: TSV4B11
• Device Lot Number: 1301556
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/19/2026
• 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: 04/08/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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 Age: 14 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic