MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® TITANIUM HEXED SCREW; DENTAL SCREW

Catalog Number	IUNIHT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10.Concomitant medical products: int610, osseotite® tapered certain® implant 6 x 10mm lot 2018070976.
Event or Problem Description
Doctor reported that implant at tooth site 27 was removed due to bone loss and infection.Patient referred pain.Crown loosening was also reported.This complaint refers to the loosening of the screw event.

• Brand Name: CERTAIN® TITANIUM HEXED SCREW
• Common Device Name: DENTAL SCREW
• 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: 24857121
• Report Number: 0001038806-2026-01989
• Device Sequence Number: 21141865
• Product Code: NHA
• UDI-Device Identifier: 00844868008545
• UDI-Public: (01)00844868008545(17)290902(10)1287373
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072642
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/02/2026

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: IUNIHT
• Device Lot Number: 1287373
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/23/2026
• 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: 04/13/2026
• Supplement Report FDA Received Date: 06/02/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic