BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CALIPER II

    MDR report key: 1170276 · Received September 11, 2008

    Report

    Report Number
    1649384-2008-00474
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE EVENT OCCURRED IN SURGERY. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    ON AUG 13, 2008, THE DISTRIBUTOR REPORTED THAT ON AN UNKNOWN DATE, THE SCREW ON THE ROD CALIPER HAD WORKED ITSELF LOOSE. THIS MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD CALIPER II PATHFINDER LXH ABBOTT SPINE 29QR

    Patients

    Seq Age Sex Outcome Treatment
    1