BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE #7 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA.

    MDR report key: 2903894 · Received December 4, 2012

    Report

    Report Number
    2249697-2012-02531
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 IN 1 CUTTING BLOCK SPIKE BROKE WHEN BEING REMOVED FROM FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE #7 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH N SB3K07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other