BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 24562960 · Received March 10, 2026

    Report

    Report Number
    0001038806-2026-01286
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    October 29, 2025
    Report Date
    May 19, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) IUNIHG, (CERTAIN® GOLD-TITE® HEXED SCREW) FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1220830. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1220830 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE EXCESSIVE OCCLUSAL FORCES - PATIENT FACTORS, OR CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, G6: CHECKED "FOLLOW-UP", H6: ENTERED EVALUATION CODES, H11: ADDED MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). H11: D10 - MEDICAL PRODUCT - T3® TAPERED IMPLANT 5/4 X 10MM CATALOG #: BOPT5410 LOT #:2017112307.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABUTMENT FRACTURED SUBSEQUENT TO A FRACTURED SCREW. REMOVED SCREW AND ABUTMENT/CROWN. RE-MACHINED INTERNAL HEX USING NEW ABUTMENT AND REPEAT SEATING. ABLE TO RESEAT NEW ENCODE PA VERIFICATION GD TO FABRICATE NEW CROWN/ABUTMENT TO REPLACE FRACTURED UNIT. BASICALLY, RE-MACHINED THE INTERNAL STRUCTURE OF IMPLANT. IMPLANT NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422653 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW DZE ZIMVIE US CORP LLC 1220830 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1