BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK/CERVICAL (BAK/C)

    MDR report key: 467731 · Received June 4, 2003

    Report

    Report Number
    MW4003520
    Event Type
    Injury
    Date Received
    June 4, 2003
    Date of Event
    February 20, 2002
    Report Date
    June 4, 2003
    Manufacturer
    SULZER SPINE TECH
    Product Code
    MAX
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/19/03: THIS LETTER IS IN RESPONSE TO LETTER DATED 24-JUNE-03 MAILED FROM FACILITY ON 15-SEPT-03, RECEIVED BY CENTERPULSE SPINE-TECH DIVISION ON 19-SEP-03, REGARDING MEDWATCH ADVERSE EVENT REPORTING PROGRAM REPORT NUMBER MW4003520. AFTER REVIEW OF LETTER, MFR BELIEVES THIS TO BE THE SAME EVENT THAT WAS REPORTED TO CENTERPULSE SPINE-TECH DIVISION UNDER MEDWATCH ADVERSE EVENT REPORT PROGRAM REPORT NUMBER MW4003552. IN SUMMARY, THE BAK CERVICAL IMPLANT(S) INDICATED BY THESE REPORTS ARE INTENDED TO FACILITATE FUSION. THE REPORT INDICATES THAT THE IMPLANT WAS EXPLANTED WITHIN SEVERAL DAYS OF INITIAL IMPLANTATION AND FUSION HAD NOT YET OCCURRED. SPINAL VERTEBRAL FUSION IS GENERALLY MONITORED THROUGH A PERIOD OF MONTHS OF POST-OPERATIVE CARE RATHER THAN DAYS, TYPICALLY REQUIRING APPROX 6 MONTHS FOR FULL SPINAL FUSION TO OCCUR. IF THE DEVICE WAS EXPLANTED PREMATURELY AS INDICATED, NON-FUSION WOULD BE EXPECTED, DUE TO THE TIMELINE NORMALLY ASSOCIATED TO FACILITATE FUSION, AND DOES NOT SUGGEST A FAILURE OF THE DEVICE. BASED ON REVIEW OF THE REPORTED INFO. SPINE-TECH DOES NOT BELIEVE THIS INCIDENT IS INDICATIVE OF ANY FAILURE OF THE BAK/C DEVICE.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT IN 2002 THEIR DOCTOR HAD SURGICALLY IMPLANTED A 'BAK SPINAL FUSION' CAGE TO HELP RELIEVE THEIR NECK AND BACK PAIN. SEVERAL DAYS LATER, PT BEGAN TO EXPERIENCE SEVERE PAIN FROM THE NEW DEVICE. IN 2003 A DIFFERENT SURGEON REMOVED THE 'BAK' UNIT AND DETERMINED THAT THE DEVICE HAD FAILURE TO PROPERLY FUSE THE TARGETED NECK BONES. THE DEVICE HAD CAUSED INSTABILITY IN THEIR ANTERIOR AND POSTERIOR SPINE AT SITE #C67.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM MAX SULZER SPINE TECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization