BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK/C

    MDR report key: 464593 · Received June 3, 2003

    Report

    Report Number
    MW1028630
    Event Type
    Injury
    Date Received
    June 3, 2003
    Date of Event
    February 20, 2002
    Report Date
    June 3, 2003
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D ON 07/10/2003: THE MODEL NUMBER AND/OR CATALOG NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT IS UNKNOWN. 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 PT'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 PT. THE LACK OF FUSION OVER THE POST-IMPLANTATION PERIOD, THE REVISION OF THE SURGICAL PROCEDURE, TO INCLUDE THE REMOVAL OF BAK/C CAGE(S), IN THE STABILIZATION OF THE SPINE FOR THIS PT, 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. THE CO HAS REVIEWED THE PERFORMANCE HISTORY OF ALL MODEL NUMBERS/LOTS OPF BAK/C DEVICES MANUFACTURED BY SPINE TECH AND HAVE DETERMINED THERE ARE NOT ANY PREVIOUSLY IDENTIFIED MALFUNCTIONS WITH BAK/C DEVICES NOT HAVE THERE BEEN ANY PRODUCT RECALLS RELATED TO ANY BAK/C DEVICES. BASED ON THIS REVIEW AND THE INFO 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 ADD'L INFO 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

    PT HAD THE BAK/C CERVICAL INTERBODY FUSION SYSTEM DONE IN 2002. PT STARTED HAVING PROBLEMS AS SOON AS THEY WERE OUT OF THE BRACE. PT WAS ALSO WEARING A BONE GROWTH STIMULATOR 3 HOURS A DAY FOR SIX MONTHS. PT WAS TOTALLY DISABLED AND HAD A LOT OF PROBLEMS MOVING THEIR NECK DOWN AND AROUND WHICH WAS THE COMPLETE OPPOSITE OF THE PROBLEM THEY WERE HAVING BEFORE THE OPERATION. PT UNDERWENT TESTING WITH ANOTHER SURGEON AND FOUND OUT THERE WAS NO BONY FUSION AT THE CAGE AND THERE WAS RESULTANT INSTABILITY OF THE ANTERIOR AND POSTERIOR COLUMNS OF THE CERVICAL SPINE AT THE CAGE SPOT. PT UNDERWENT SURGERY IN 2003 TO HAVE THE CAGE REMOVED AND STABILIZE THEIR SPINE. THIS HAD TO BE DONE POSTERIOR AND ANTERIOR WITH PLATING FRONT AND BACK. FRONT PLATING HAD TO GO FROM C5 TO T1 DUE TO SIGNIFICANT AMOUNTS OF THE VERTIBRAL BODIES OF C6 AND C7 ABSENT. SO THEY HAD TO DO DISCECTOMIES ON THE AREAS AND THE PLATING INSTALLED.

    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 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-03 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 OF 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 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).

    Devices

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

    Patients

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