BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK JIG

    MDR report key: 2191418 · Received July 28, 2011

    Report

    Report Number
    9610622-2011-00334
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON USED OLD RECON JIG AND THE TWO LAG SCREWS MISSED THE NAIL COMPLETELY THEREFORE THIS PT HAD TO BE REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK JIG INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention