BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINE-TECH BAK INTERBODY FUSION DEVICE

    MDR report key: 247890 · Received November 3, 1999

    Report

    Report Number
    MW1017453
    Event Type
    Other
    Date Received
    November 3, 1999
    Date of Event
    January 3, 1997
    Report Date
    November 3, 1999
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD DEVICE IMPLANTED IN 1997. BEFORE HER SURGERY, ON A SCALE OF 1-10, HER PAIN WAS A ONE. AFTER SURGERY IT WAS A TEN. BECAUSE OF HER PAIN, 3-6 MONTHS AFTER SURGERY A CAT SCAN WAS DONE TO DETERMINE IF FUSION WAS ACHIEVED. DR WAS UNABLE TO MAKE THE DETERMINATION BECAUSE OF THE TITANIUM THE DEVICE IS MADE OF. RPTR QUESTIONS IF IT CAN BE DETERMINED BY CAT SCAN AND IF THAT IS NOT THE CASE HOW MFR CAN CLAIM THAT IN CLINICAL TRIALS IT ACHIEVED APPROX. 90% FUSION IN 1200 PEOPLE AT 6 HOSPITALS. IN ADDITION, ON THE INTERNET MFR STATES IT HAS A 4.4% REOPERATION RATE WITH PATIENTS IT HAS NOT FOLLOWED FOR 2 YRS, THE AMOUNT OF TIME THE FOUNDER OF THE CO SAYS IS INADEQUATE TO ACHIEVE FUSION. ACCORDING TO RPTR, MFR'S FOUNDER CLAIMS THAT IT TAKES 4-6 YRS FOR FUSION TO OCCUR. RPTR HAD A REVISION IN NOVEMBER OF 1997 WHERE A SECOND SURGEON USED BONE SUBSTITUTE. SHE IS STILL EXPERIENCING PAIN BUT NO LONGER HAS TO TAKE NARCOTICS. RPTR IS CONCERNED THAT MFR IS USING INFLATED PERCENTAGES OF SUCCESS AND SHE ALSO VOICES CONCERN THAT HER INITIAL PHYSICIAN WHO SAYS HE HAD IMPLANTED 22 OF THESE DEVICES IN 1996 WITH REVISIONS OF 10 WAS TRAINING OTHER PHYSICIANS TO IMPLANT THIS DEVICE WHEN HIS REVISION RATE IS CLOSE TO 50%. HER PHYSICIAN ALSO SAID HE HAD PTS WHO WERE WORSE AFTER SURGERY. RPTR IS CONCERNED THAT FDA DIDN'T GET HONEST STATISTICS CONCERNING THE SUCCESSFUL USE OF THIS DEVICE AND THAT IF PEOPLE KNEW IT TOOK SO LONG FOR FUSION, THAT THEY WOULD NOT CHOOSE TO HAVE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE-TECH BAK INTERBODY FUSION DEVICE Implant SPINAL CAGE MAX SULZER SPINE-TECH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other