BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM TNS

    MDR report key: 2072762 · Received March 31, 2011

    Report

    Report Number
    9610622-2011-00147
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE CONNECTION BETWEEN THE CARBON TARGETING ARM, AND THE METAL NAIL HOLDING ARM, WAS VERY LOOSE. YOU COULD SEE IT JIGGLING. CASE COMPLETED AS ORIGINALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM TNS INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA TBA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other