MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN GOLD-TITE HEXED SCREW; DENTAL SCREW

Catalog Number	IUNIHG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a fracture of three of the prosthetic screws at the threaded part in a patient with a mandibular hybrid prosthesis on four implants (tooth site 32,34,42,44), so it was decided to replace all of them, taking into account the possible oclusal overload.Patient suffered prosthesis mobility and inflammation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.D10.Concomitant medical products.Ilrghg, certain gold-tite large hexed screw lot 1250285.Ilrghg, certain gold-tite large hexed screw lot 1196425.

• Brand Name: CERTAIN GOLD-TITE 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: 25064950
• Report Number: 0001038806-2026-02426
• Device Sequence Number: 9427065
• Product Code: NHA
• UDI-Device Identifier: 00844868008538
• UDI-Public: (01)00844868008538(17)290519(10)1280761
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Report Date (Section B): 06/19/2026

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: IUNIHG
• Device Lot Number: 1280761
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/15/2026
• 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
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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 SCREW SEE H10 NARRATIVE
• Patient Age: 74 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic