BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH MEASURING GAUGE FOR 2.7MM SCREWS

    MDR report key: 1864621 · Received October 7, 2010

    Report

    Report Number
    8010177-2010-00370
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED FOR ANALYSIS. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEPTH GAUGE BROKE AND HAD TO USE THE 3.5 DEPTH GAUGE. PROCEDURE WAS COMPLETED AS ORIGINALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPTH MEASURING GAUGE FOR 2.7MM SCREWS INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK