BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4920938 · Received July 10, 2015

    Report

    Report Number
    4920938
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCREW DRILLED INTO PT. OUTSIDE OF SCREW STRIPPED OFF, THEN BROKE OFF INTO PT. PART OF SCREW REMOVED BUT SURGEON WAS UNABLE TO REMOVE THE ENTIRE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451217 * SCREW HWC SYNTHES (USA) PRODUCTS LLC 207.742 *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR