MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM; DENTAL IMPLANT

Catalog Number	TSVB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Osteolysis (2377)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #13 was removed due to infection and bone loss.The patient returned on (b)(6) 2014 for the placement of implant at tooth site #13.Subsequent examinations on (b)(6) 2014 noted that all healing was within normal limits, as such implant was restored on (b)(6) 2014.The patient returned on (b)(6) 2026 complaining of pain and a possible infection.X-ray imaging confirmed bone loss.The implant was removed and the site was debrided.The patient started on amoxicillin 500 mg.The patient anticipated returning on (b)(6) 2026 for a re-evaluation of a future bone graft.Symptoms as a result of the event: abscess and pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.G4: additional pma/510(k) number ¿ k101880.A summary investigation has been completed for bone loss and infection events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss and infection have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
• 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: 24569995
• Report Number: 0001038806-2026-01307
• Device Sequence Number: 8366777
• Product Code: DZE
• UDI-Device Identifier: 00889024019522
• UDI-Public: (01)00889024019522(17)180731(10)62424965
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: TSVB13
• Device Lot Number: 62424965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• 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: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2013
• 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: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic