BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK/CERVICAL (BAK/C)

    MDR report key: 476376 · Received July 21, 2003

    Report

    Report Number
    MW4003552
    Event Type
    Injury
    Date Received
    July 21, 2003
    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

    DR HAD SURGICALLY IMPLANTED A 'BAK SPINAL FUSION' CAGE TO HELP RELIEVE THEIR NECK AND BACK PAIN. SEVERAL DAYS LATER, THEY BEGAN TO EXPERIENCE SEVERE PAIN FROM THE NEW DEVICE. THE NEXT DAY, A DIFFERENT SURGEON REMOVED THE 'BAK' UNIT AND DETERMINED THAT THE DEVICE HAD FAILED TO PROPERLY FUSE THE TARGETED NECK BONES. THE DEVICE HAD CAUSED INSTABILITY IN ANTERIIOR AND POSTERIOR SPINE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/29/03: AFTER REVIEW OF LETTER, AND REVIEW OF HISTORICAL COMPLAINT FILES, CO HAS DETERMINED THAT THIS IS AN EVENT THAT HAS PREVIOUSLY BEEN CATALOGUED BY SPINE-TECH. SPINE-TECH RECEIVED A LETTER FROM THE FDA DATED 16-JUNE-2003 WITH AN ATTACHMENT, MEDWATCH ADVERSE EVENT REPORTING PROGRAM REPORT NUMBER MW1028630. A COPY OF CO'S ORIGINAL RESPONSE LETTER IS PROVIDED AS AN ENCLOSURE TO THIS LETTER FOR FDA'S RECORDS. THE ENCLOSED LETTER WAS ORIGINALLY SENT ON 11-JULY-2003 IN RESPONSE TO MEDWATCH REPORT NUMBER MW1028630. THIS LETTER IS IN RESPONSE TO FDA'S LETTER DATED 16-JUN-03 REGARDING MEDWATCH ADVERSE EVENT REPORTING PROGRAM REPORT NUMBER MW1028630. AFTER REVIEW LETTER, AND REVIEW OF HISTORICAL COMPLAINT FILES, CO HAS DETERMINED THAT THIS IS AN EVENT THAT HAS PREVIOUSLY NOT BEEN REPORTED TO SPINE-TECH. 1. THE MODEL NUMBER AND/OR CATALOG NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT IS UNKNOWN. THE INFORMATION PROVIDED IN THE REPORT ACCOMPANYING LETTER WAS EITHER UNAVAILABLE OR REDACTED WHEN FORWARDED TO SPINE-TECH. 2. THE MANUFACTURING LOT AND/OR SERIAL NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT IS UNKNOWN. THE INFORMATION PROVIDED IN THE REPORT ACCOMPANYING LETTER WAS EITHER UNAVAILABLE OR REDACTED WHEN FORWARDED TO SPINE-TECH. 3. AS PREVIOUSLY STATED, IT IS SPINE-TECH'S BELIEF THAT THIS REPORT HAS NOT BEEN PREVIOUSLY COMMUNICATED TO SPINE-TECH. REVIEW OF THE INFORMATION PROVIDED VIA THE MEDWATCH INDICATES LACK OF THE FUSION AT C6-C7 AS THE CAUSE OF THE PATIENT'S CLINICAL CONDITION. ALTHOUGH UNFORTUNATE, LACK OF FUSION DOES OCCUR IN A SMALL PERCENTAGE OF CASES, BUT DOES NOT NECESSARILY CONSTITUTE A FAILURE OF THE DEVICE. LACK OF FUSION IS TYPICALLY ATTRIBUTABLE TO A PATIENT'S PRE-EXISTING CLINICAL CONDITION OR A SPECIFIC METABOLIC CONDITION (E.G. SMOKING). IN THIS CASE, THE REPORTED USE BONE GROWTH STIMULATOR MAY ALSO SUGGEST A PRE-EXISTING CLINICAL OR METABOLIC CONDITION OF THE PATIENT. THE LACK OF FUSION OVER THE POST-IMPLANTATION PERIOD, THE REVISION OF THE SURGICAL PROCEDURE, TO INCLUDE THE REMOVAL OF THE BAK/C CAGE(S), IN THE STABILIZATION OF THE SPINE FOR THIS PATIENT, AND THE IMPLANTATION OF CERVICAL PLATING ARE NORMAL AND EXPECTED CLINICAL ALTERNATIVES TO ACHIEVE SPINAL STABILIZATION, HOWEVER DO NOT CONSTITUTE A FAILURE, EITHER EXPLICITLY OR IMPLICITLY, OF THE INITIALLY IMPLANTED BAK/C CAGE MEDICAL DEVICE(S) ITSELF. THIS EVENT HAS BEEN LOGGED AS A COMPLAINT WITH SPINE-TECH. CO HAS REVIEWED THE PERFORMANCE HISTORY OF ALL MODEL NUMBERS/LOTS OF BAK/C DEVICES MANUFACTURED BY SPINE-TECH AND HAS DETERMINED THERE ARE NOT ANY PREVIOUSLY IDENTIFIED MALFUNCTIONS WITH BAK/C DEVICES NOR HAVE THERE BEEN ANY PRODUCT RECALLS RELATED TO ANY BAK/C DEVICES. BASED ON THIS REVIEW AND THE INFORMATION PROVIDED IN THIS CASE, SPINE-TECH HAS CONCLUDED THAT THIS INCIDENT DOES NOT INDICATE A MALFUNCTION OF THE BAK/C DEVICE. THIS COMPLAINT FILE HAS BEEN CLOSED AT THIS TIME AND WILL NOT BE REOPENED UNLESS ADDITIONAL INFORMATION CAN BE PROVIDED THAT WOULD SUGGEST THAT THE CLINICAL OUTCOME OF THIS CASE WAS RELATED TO THE PERFORMANCE OF THE DEVICE(S).

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 09/09/03: AFTER REVIEW OF LETTER, MFR BELIEVES THIS TO BE AN EVENT THAT HAS NOT PREVIOUSLY BEEN REPORTED TO CENTERPULSE SPINE-TECH DIVISION. THE MODEL NUMBER AND/OR CATALOG NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT CANNOT BE DETERMINED BASED ON THIS REPORT. THE MANUFACTURING LOT AND/OR SERIAL NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT CANNOT BE DETERMINED BASED ON THIS REPORT. AS PREVIOUSLY STATED, IT IS SPINE-TECH'S BELIEF THAT THIS REPORT HAS NOT BEEN PREVIOUSLY SUBMITTED TO CENTERPULSE SPINE-TECH. THE BAK CERVICAL IMPLANTS 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 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.

    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