BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE, G3 PLUS

    MDR report key: 2192492 · Received June 30, 2011

    Report

    Report Number
    9610622-2011-00287
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 14, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, "TARGETING ARM CHIPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE, G3 PLUS INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KIME902874

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other