BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAGMENT CONTROL CLIP

    MDR report key: 1861325 · Received October 4, 2010

    Report

    Report Number
    9610622-2010-00430
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 21, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM CENTRAL STERILIZATION DEPT VIA FAX THAT THE PRODUCT FELL INTO TWO PIECES. THE SURGERY WAS FINALIZED WITH THE INSTRUMENT PARTS BEING HOLD TOGETHER MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAGMENT CONTROL CLIP INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KME901091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other