BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK SLEEVE 180

    MDR report key: 1981653 · Received January 12, 2011

    Report

    Report Number
    9610622-2011-00014
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 22, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEAD OF THEATRE, REPORTS VIA OUR SALES REP, THAT THE LOCKING SCREW SLIPPED OUT OF THE TARGETING SLEEVE BUT COULD BE PUSHED IN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDLOCK SLEEVE 180 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP302680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other