BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1240983 · Received November 6, 2008

    Report

    Report Number
    1030489-2008-00621
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K072317
    Removal / Correction Number
    1824199-103108-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION DETERMINED THAT THE CONNECTORS' THREADED COMPONENTS FAILED DURING TIGHTENING OF THE SETSCREWS. IT APPEARS THE WALL THICKNESS NEAR THE SCREW POST HOLE IS UNDERSIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SINGLE LEVEL SURGERY FOR IMPLANT OF POSTERIOR FIXATION, THREE CONNECTORS WERE BROKEN DURING IMPLANT. FINALLY A FOURTH WAS IMPLANTED WITH NO ISSUES AND THE SURGERY WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM CONNECTOR KWP WARSAW ORTHOPEDIC INC. NA W08J0633

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK