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

Catalog Number	IUNIHG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a screw fractured inside of the implant at tooth site #21.The screw was suctioned during removal.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.The device will not be returned for analysis as the screw was suctioned during removal; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: CERTAIN GOLD-TITE TM 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: 24941729
• Report Number: 0001038806-2026-02169
• Device Sequence Number: 14849386
• Product Code: NHA
• UDI-Device Identifier: 00844868008538
• UDI-Public: (01)00844868008538(17)310120(10)4110000816
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: 4110000816
• Was Device Available for Evaluation?: No
• 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: 04/21/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2026
• 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: UNKNOWN IMPLANT
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic