BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 24870137 · Received April 14, 2026

    Report

    Report Number
    0001038806-2026-02022
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS. TSV4B10, IMP, TSV,4.1MM, SBM,10 LOT 1233733. G4: PREMARKET IDENTIFICATION UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 45 WAS REMOVED DUE TO A BONE LOSS, THE IMPLANT FRACTURE AT THE BODY AND A SCREW FRACTURE INSIDE THE IMPLANT. IT WAS IMPOSSIBLE TO REMOVE THE IMPLANT WITH ZIMMER INSTRUMENT AVAILABLE. THE PROCEDURE REQUIRED EXPLANTATION USING A TREPHINE BUR, FOLLOWED BY A BONE GRAFT WITH BIOMATERIALS. PATIENT SUFFERED FROM PAIN. THIS CASE REFERS TO THE SCREW FRACTURED INSIDE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541749 DENTAL SCREW DZE ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1