BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM PROX. LAT TIBIA LEFT

    MDR report key: 2441830 · Received February 2, 2012

    Report

    Report Number
    8031020-2012-00039
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 16, 2012
    Report Date
    January 18, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED PRODUCT - (B)(4) TARGETING ARM PROX. LAT. TIBIA RIGHT LOT KP326924, (B)(4) ADAPTER NUT LOT K242670.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA PROFESSIONAL EDUCATION MANAGER THAT DURING A DEMO ((B)(6) 2012) IT WAS DETECTED THAT: "WHEN INSERTING THE TARGETING ARM MARKETING PEOPLE DISCOVERED A MALALIGNMENT WITH THE MOST DISTAL HOLE OF THE TIBIA PLATE". IT HAS BEEN REPORTED VIA MARKETING THAT "SHE CAN NOT ASSURE THE CORRECT ALIGNMENT OF THE ARM WITH THE PLATE DISTALLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM PROX. LAT TIBIA LEFT INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA KP326924

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other