MAUDE Adverse Event Report: ZimVie US Corp LLC IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM; Dental Implant

Catalog Number	TSVB11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed due to a fracture at the collar.The patient had received a prosthetic restoration that was not an original zimvie product.During this period, the patient returned repeatedly to have the crown tightened because it continued to loosen.This year, it was decided to replace the crown using a new original zimvie abutment.However, when the impression was taken, it was noted that the prosthesis would not fit into the implant hex.Upon further evaluation, it was observed that the implant was slightly fractured at the collar.After the healing period, a new implant with an original abutment will be placed.Tooth site 46.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.G4: premarket identification pma/510(k) #: k013227.

• Brand Name: IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
• 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 ; +1(561)971-3230
• MDR Report Key: 50096833
• Report Number: 0001038806-2026-04076
• Device Sequence Number: 18761685
• Product Code: DZE
• UDI-Device Identifier: 00889024019515
• UDI-Public: (01)00889024019515(17)280206(10)1263512
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: TSVB11
• Device Lot Number: 1263512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 154 LB