MAUDE Adverse Event Report: ZimVie US Corp LLC IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM; Dental Implant

Catalog Number	TSVWB10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the implant did not disengage the mount.The implant was removed and another implant was placed.No impact on the patient was reported.Restoration soft tissue graft performed.Tooth site 30.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: patient weight unknown / not provided.D9: device availability unknown / not provided.G4: premarket identification k011028/k013227.

• Brand Name: IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 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 ; +1(561)971-3230
• MDR Report Key: 50691084
• Report Number: 0001038806-2026-04728
• Device Sequence Number: 9595708
• Product Code: DZE
• UDI-Device Identifier: 00889024020047
• UDI-Public: (01)00889024020047(17))210430(10)63325685
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: TSVWB10
• Device Lot Number: 63325685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2016
• 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
• Patient Age: 60 YR
• Patient Sex: Male