BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLITTING OSTEOTOME, 21.5 CM, 10 MM WIDE

    MDR report key: 2445411 · Received January 26, 2012

    Report

    Report Number
    8010177-2012-00014
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 3, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS - FREIBURG
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    DURING OPERATION OSTEOTOME BROKE. IT WAS FIRST TIME USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPLITTING OSTEOTOME, 21.5 CM, 10 MM WIDE INSTRUMENT HWM STRYKER OSTEOSYNTHESIS - FREIBURG NA AB11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK