BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECOMET

    MDR report key: 11607199 · Received April 2, 2021

    Report

    Report Number
    11607199
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 23, 2021
    Manufacturer
    TECOMET INC.
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FRAGMENT OF THE BROKEN TIP OF THE SCREW EXTRACTION INSTRUMENT EMBEDDED IN THE HEAD OF THE SCREW WAS EXTRACTED BY SURGEON USING HIGH SPEED BURR DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508178 TECOMET EXTRACTOR HWB TECOMET INC. RS1020591

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA