BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1161244 · Received September 11, 2008

    Report

    Report Number
    1030489-2008-00505
    Event Type
    Injury
    Date Received
    September 11, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 15, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K030285
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR REDUCTION OF SPONDYLOLISTHESIS AT L5-S1 WITH POSTERIOR FIXATION AND BONE GRAFT. IT WAS REPORTED THAT SPONDY REDUCTION WAS LOST POST-OP DUE TO THE CONNECTOR SLIPPING ON THE SCREW. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE HARDWARE. SURGEON COMMENTED THAT THERE WAS HIGH LOADING ON THE SCREWS THAT CONTRIBUTED TO IMPLANT FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention