BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TARGETER

    MDR report key: 2945748 · Received January 4, 2013

    Report

    Report Number
    9610622-2013-90008
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED,ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOING A T2 ANKLE, WHEN TO PUT IN TA SCREW AND MISSED. SURGEON TOOK SCREW OUT AND LEFT IT WAY IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5047 UNKNOWN TARGETER INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other