BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK/PROXIMITY

    MDR report key: 447547 · Received March 7, 2003

    Report

    Report Number
    MW1027792
    Event Type
    Injury
    Date Received
    March 7, 2003
    Date of Event
    July 10, 1998
    Report Date
    February 25, 2003
    Manufacturer
    CENTERPULSE SPINE-TECH (SULZER-SPINETECH)
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SURGERY IN 1998. L5-S1 POSTERIOR LATERAL INTERBODY FUSION AND BAK CAGE IMPLANTS. REPORTER HAS BEEN ADVISED BY SEVERAL DOCTORS THAT THE IMPLANTS WERE RECALLED. THE SURGERY WAS A FAILURE AS THE FUSION DID NOT WORK AND THE IMPLANTS HAVE NOW SHIFTED. REPORTER HAS BEEN IN CHRONIC PAIN EVER SINCE. REPORTER WAS NOT ADVISED OF THE RECALL FROM THE MANUFACTURER OR THE NEURO-SURGEON THAT PERFORMED THE SURGERY. RPTR WAS TOLD BY ANOTHER DR. IN JULY 2002 THAT IMPLANTS WERE RECALLED.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 5/29/03: THE NUMBER REFERENCED BY THE MEDWATCH REPORT IS IDENTIFIABLE AS A SPINE-TECH PART NUMBER. A MEDWATCH MFR'S REPORT WAS NOT PREVIOUSLY SUBMITTED FOR THIS INCIDENT. A REVIEW OF CO'S COMPLAINT HISTORY, AND INCIDENT/EVENT RECORDS, DO NOT REFLECT HAVING PREVIOUSLY RECEIVED A RECORD OF THIS INCIDENT. THIS EVENT IS CURRENTLY RECORDED AS SPINE-TECH COMPLAINT FILE #2941 HAVING BEEN RECEIVED ON 16-APR-2003. SPINE-TECH HAS BEEN UNABLE, TO DATE, TO CONTACT REPORTER AT THE CONTACT NUMBER CONTAINED WITHIN THE MEDWATCH REPORT. THE CLAIMS WITHIN THE MEDWATCH REPORT REGARDING A RECALL OF THE DEVICE ARE UNFOUNDED. A REVIEW OF CO'S RECORDS INDICATES THAT THIS DEVICE HAS NEVER BEEN THE SUBJECT OF A RECALL. ADDITIONALLY, THE MEDWATCH REPORTED THAT THE "FUSION DID NOT WORK". WHILE A PT'S FAILURE TO ACHIEVE FUSION FOLLOWING IMPLANT SURGERY IS UNFORTUNATE, IT IS NOT INDICATIVE OF A FAILURE OF THE MEDICAL DEVICE ITSELF. WITHOUT ADD'L INFO RELATED TO THE CLINICAL DIAGNOSIS OF THE PT'S CONDITION, SURGEON NOTES, PRODUCT LOT NUMBERS, CLINICAL CONDITIONS, ETC., SPINE-TECH IS UNABLE TO INVESTIGATE THIS EVENT FURTHER. THE COMPLAINT FILE ASSOCIATED WITH THIS MEDWATCH WILL BE CLOSED. SPINE-TECH STANDARD PROCEDURES WOULD DICTATE THE NECESSITY OF REOPENING COMPLAINT FILES IN THE EVENT THAT ADD'L OR SUPPLEMENTAL INFO IS FORWARDED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK/PROXIMITY INTERBODY DEVICE MAX CENTERPULSE SPINE-TECH (SULZER-SPINETECH) 13 X 20MM *
    2 SPINETECH INTRABODY IMPLANTS BACK CAGE IMPLANTS MAX CENTERPULSE SPINETECH (SULZER-SPINETECH) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R| S