BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DRILL AND HANDPIECE

    MDR report key: 1735768 · Received June 24, 2010

    Report

    Report Number
    6000034-2010-00392
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    W&H
    Product Code
    ERL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE SURGEON, THE DRILL DID NOT STOP AT THE SELECTED TORQUE SETTING CAUSING THE SCREW TO STRIP FROM THE BONE. THE FIXTURE WAS LEFT IN PLACE, AND AN ADDITIONAL FIXTURE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRIC DRILL AND HANDPIECE ERL ERL W&H 04009800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention