BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1030256 · Received April 17, 2008

    Report

    Report Number
    1030489-2008-00199
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    March 24, 2008
    Manufacturer
    WARSAW ORTHOPEDICA INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PT UNDERWENT A TWO-LEVEL PLIF AT L4-S1 USING TWO RESORBABLE INTERBODY DEVICES AT EACH LEVEL PACKED WITH ILIAC CREST BONE GRAFT, A SUPPLEMENTED WITH PEDICLE SCREW FIXATION, RODS AND TWO CROSSLINKS. THE PT EXPERIENCED A TRAUMATIC FALL APPROX SEVEN MOS POST-OP. THERE WAS NO EVIDENCE OF NEW LUMBOSACRAL INJURY NOTED IMMEDIATELY POST-FALL, BUT THE PT DID REPORT MARKED EXACERBATION OF BACK PAIN AFTERWARD. CONTINUED RADIOGRAPHIC MONITORING ULTIMATELY NOTED NON-UNION AT BOTH LEVELS WITH SUBSEQUENT FRACTURE OF BILATERAL SACRAL SCREWS NOTED APPROX 16 MONTHS POST-OP. A REVISION SURGERY WAS PERFORMED APPROX TWENTY-THREE MONTHS POST-OP TO REMOVE THE BROKEN HARDWARE. X-RAYS TAKEN TWO WEEKS POST-REVISION NOTED A SCREW REMNANT IN THE SACRUM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention