MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM; DENTAL IMPLANT

Catalog Number	TSVWB8
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: premarket identification pma/510(k) #: k011028|k013227.
Event or Problem Description
Doctor reports after placing the implant at tooth site 36, it did not obtain primary stability and also they could not disengage the mount.They could finally forcibly remove it and placed another implant of the same type in position.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).

• Brand Name: IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
• 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: 24828736
• Report Number: 0001038806-2026-01897
• Device Sequence Number: 18433987
• Product Code: DZE
• UDI-Device Identifier: 00889024020085
• UDI-Public: (01)00889024020085(17)291126(10)1293767
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061410
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2026

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: TSVWB8
• Device Lot Number: 1293767
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/17/2026
• 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; Not provided
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic