BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 25247224 · Received May 21, 2026

    Report

    Report Number
    0001038806-2026-02837
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(6). A4: WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: CATALOG AND LOT NUMBER UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER NOT AVAILABLE. PRODUCT HAS BEEN RECEIVED BY ZIMVIE AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING PRODUCT EVALUATION. A FRACTURED SCREW WAS FOUND INSIDE OF THE IMPLANT. UPON FOLLOW UP, THE CUSTOMER WAS UNAWARE OF THE FRACTURED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241014 DENTAL SCREW DZE ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1