BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1850022 · Received September 27, 2010

    Report

    Report Number
    9610622-2010-00405
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 13, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE NURSE FROM (B)(6) ADVISED ME THAT THE DISTAL SCREW IN THE GAMMA TARGETING DEVICE DID NOT LINE UP PROPERLY DURING SURGERY ON THE (B)(6) 2010. UPON MY INVESTIGATION OF THE DEVICE, I FOUND 2 CRACKS. ANOTHER DEVICE WAS AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other