BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 24839607 · Received April 10, 2026

    Report

    Report Number
    0001038806-2026-01948
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW FRACTURED IN THE PATIENT'S MOUTH. REQUESTED SCREW REMOVAL TOOLS IN ORDER TO RETRIEVE THE BROKEN PORTION FORM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438446 DENTAL SCREW DZE ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN IMPLANT