BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ICN.

    MDR report key: 141328 · Received December 16, 1997

    Report

    Report Number
    MW1012724
    Event Type
    Injury
    Date Received
    December 16, 1997
    Date of Event
    November 20, 1995
    Report Date
    December 16, 1997
    Manufacturer
    DEPUY INC.
    Product Code
    JDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD AN ANTERIOR LUMBAR FUSION AT L-4, L-5, L-5-S-1, ON 11/20/95. RPTR WAS TOLD THAT THEY WOULD BE OUT OF PAIN OR HAVE VERY LITTLE PAIN WITHIN SIX MOS AFTER SURGERY. IT IS NOW TWO YRS, 1 MO LATER AND RPTR'S PAIN JUST GETS WORSE DAILY. BEFORE SURGERY RPTR HAD NO NERVE DAMAGE OF ANY KIND THROUGH A SERIES OF TESTS, AND NOW TESTS SHOW PERMANANT NERVE DAMAGE TO THE AREA THE SURGERY WAS PERFORMED ON. RPTR RECENTLY FOUND OUT, THAT BY LAW, THE CAGES AND SCREWS IMPLANTED WERE IN FACT EITHER ILLEGAL OR RPTR WAS SUPPOSED TO SIGN AN INVESTIGATIONAL DEVICE CONSENT FORM WHICH NEVER WAS TOLD TO RPTR OR EVEN GIVEN TO RPTR PRIOR TO THEIR SURGERY. IF RPTR WOULD HAVE KNOWN ANY OF THIS RPTR WOULD NOT HAVE HAD THIS SURGERY DONE. RPTRS PAIN IS SEVERE AT TIMES & DOWN THEIR RT LEG. RPTR HAD SEVERAL CORTISONE INJECTIONS AFTER SURGERY; ONE YR AFTER SURGERY (1997) EARLY, MYELOGRAM AS WELL AND TESTS EITHER DID NOT HAVE ANY RESPONSE OR SHOWED POSSIBLE NERVE DAMAGE TO THE SURGICAL AREA. THE MED CTR STATED THAT RPTR'S SURGERY WAS A COMPLETE AND TOTAL FAILURE AND THAT RPTR NOW HAS PERMANANT NERVE DAMAGE (09-97).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ICN. Implant DEPUY-LORDOTIC HARMES CAGES SPINAL IMPLANTS JDN DEPUY INC. NI *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention| S