BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 25173095 · Received May 14, 2026

    Report

    Report Number
    0001038806-2026-02676
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PMA/510(K) NUMBER NOT AVAILABLE. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMVIE FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DISLODGED IMPLANT CROWN AT TOOTH SITE #5. THE CROWN WAS INSERTED IN 2025 WITHOUT COMPLICATION USING THE GOLD-TITE HEXED SCREW AND CERTAIN STRAIGHT GINGIHUE POST/ABUTMENT. THE SCREW HAS BROKEN. WE HAVE THE ABUTMENT WITH CEMENTED CROWN AND PROTRUDING PIECE OF THE SCREW BUT COULD NOT LOCATE OR RETRIEVE ANY REMAINING SCREW IN THE IMPLANT. WE ASSUME IT WAS LOST. THE IMPLANT IS STILL IN THE PATIENT'S MOUTH WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611772 DENTAL SCREW NHA ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male UNKNOWN IMPLANT