MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM; DENTAL IMPLANT

Catalog Number	TSVB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.G4: premarket identification k011028/k013227.
Event or Problem Description
It was reported that an implant at tooth site # 36 was removed due to a fracture at the implant collar.Procedure was not completed.

• Brand Name: IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
• 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: 25388937
• Report Number: 0001038806-2026-03022
• Device Sequence Number: 5205156
• Product Code: DZE
• UDI-Device Identifier: 00889024019508
• UDI-Public: (01)00889024019508(17)280624(10)1268407
• 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: 2023
• 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
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TSVB10
• Device Lot Number: 1268407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• 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: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic