BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL SCREW

    MDR report key: 17850068 · Received October 2, 2023

    Report

    Report Number
    0002023141-2023-02704
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    May 30, 2023
    Report Date
    October 1, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). D10. CONCOMITANT MEDICAL PRODUCTS TSVWB8, IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM LOT 1221513. SINCE THE LOT NUMBER AND DEVICE WILL NOT BE RETURNED , IDENTIFYING A DEFINITIVE ROOT CAUSE WILL NOT BE POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATED THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WOULD BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED CROWN PLACED AND LOOSENED. DOCTOR FINALLY REMOVED THE IMPLANT AND NOTICED THAT THE IMPLANT HEX WAS DAMAGED. TOOTH LOCATION 52.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971176 DENTAL SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female DENTAL IMPLANT SEE H10 NARRATIVE