BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT 2.5X230MM AO FITTING

    MDR report key: 1864976 · Received October 5, 2010

    Report

    Report Number
    8031020-2010-00135
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 24, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    GFG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. NO EVAL WILL BE PERFORMED. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, SURGEON COULD NOT READ THE CALIBRATION ON THE DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT 2.5X230MM AO FITTING IMPLANT GFG STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other