BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4780460 · Received May 19, 2015

    Report

    Report Number
    2530088-2015-10354
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    October 19, 2012
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN PRODISC-L IMPLANTS (SUPERIOR ENDPLATE), UNKNOWN QUANTITY / UNKNOWN LOT. (B)(6). (B)(4). CHANGES IN ALD, DECREASE IN INDEX LEVEL ROM AT 5 YEARS, HERNIATED NUCLEUS PULPOSUS, SPINAL CORD STIMULATOR WAS IMPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SPINAL CORD STIMULATOR WAS IMPLANTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZIGLER, J., ET AL. (2012). FIVE-YEAR ADJACENT-LEVEL DEGENERATIVE CHANGES IN PATIENTS WITH SINGLE-LEVEL DISEASE TREATED USING LUMBAR TOTAL DISC REPLACEMENT WITH PRODISC-L VERSUS CIRCUMFERENTIAL FUSION. J NEUROSURG: SPINE 17:504-511. USA. THE STUDY OBJECTIVE WAS TO REPORT THE 5-YEAR RESULTS FOR RADIOGRAPHICALLY DEMONSTRATED ADJACENT-LEVEL DEGENERATIVE (ALD) CHANGES FROM A PROSPECTIVE MULTICENTER STUDY IN WHICH PATIENTS WERE RANDOMIZED TO EITHER TOTAL DISC REPLACEMENT (TDR) OR CIRCUMFERENTIAL FUSION FOR SINGLE-LEVEL LUMBAR DEGENERATIVE DISC DISEASE (DDD). THE STUDY INCLUDED TWO HUNDRED AND THIRTY-SIX PATIENTS WITH SINGLE-LEVEL LUMBAR DDD ENROLLED FROM OCTOBER, 2001 TO JUNE, 2003. THEY WERE ASSIGNED TO 2 TREATMENT GROUPS: 161 PATIENTS IN THE TDR GROUP WERE TREATED USING THE PRODISC-L, AND 75 PATIENTS WERE TREATED WITH CIRCUMFERENTIAL FUSION. THERE IS NO INDICATION THAT THE DEVICES USED FOR FUSION WERE SYNTHES DEVICES. VARIOUS SCALE AND TEST EVALUATIONS WERE USED TO MEASURE PATIENT OUTCOMES. RADIOGRAPHIC FOLLOW-UP DATA 5 YEARS AFTER TREATMENT WERE AVAILABLE FOR 123 TDR PATIENTS BASED ON A TOTAL OF 163 TDR LEVELS. IN GENERAL, PATIENTS HAD SINGLE-LEVEL DDD BETWEEN L3-S1, BACK AND/OR LEG PAIN, AN ODI SCORE >/- 40%, AND AT LEAST 6 MONTHS OF FAILED CONSERVATIVE TREATMENT. THE TDR GROUP CONSISTED OF 62 MALES AND 61 FEMALES. THE MEAN AGE IN YEARS WAS 38.3. THREE PATIENTS (3) WERE IMPLANTED AT INDEX LEVEL L3-4, FORTY-FIVE (45) PATIENTS AT L4-5, AND SEVENTY-FIVE (75) PATIENTS AT L5-S1. CHANGES IN ALD AT 5 YEARS WERE OBSERVED IN 9.2% OF TDR PATIENTS. AMONG THE PATIENTS WITHOUT ADJACENT-LEVEL DISEASE PREOPERATIVELY, NEW FINDINGS OF ALD AT 5 YEARS POST TREATMENT WERE APPARENT IN 6.7 % TDR PATIENTS. THE TDR PATIENTS HAD A SLIGHT DECREASE IN INDEX LEVEL ROM AT 5 YEARS. ADJACENT-LEVEL SURGERY LEADING TO SECONDARY SURGERY WAS REPORTED FOR 1.9% OF TDR PATIENTS. ONE YEAR AFTER AN L5¿S1 INDEX SURGERY, 1 TDR PATIENT UNDERWENT FUSION AT THE L4¿5 LEVEL AND A BILATERAL LAMINECTOMY AT L3¿4 DUE TO BACK AND LEG PAIN WITH NUMBNESS. ONE TDR PATIENT UNDERWENT FUSION AT THE L4¿S1 LEVEL 5 YEARS AFTER AN L5¿S1 INDEX SURGERY; THE TDR WAS LEFT INTACT. FIVE YEARS AFTER L5¿S1 SURGERY, THE THIRD TDR PATIENT SUFFERED A HERNIATED NUCLEUS PULPOSUS AND UNDERWENT A DISCECTOMY AT L4¿5. WHILE NOT CONSIDERED ADJACENT-LEVEL SURGERY, A SPINAL CORD STIMULATOR WAS IMPLANTED IN A FOURTH L4¿5 TDR PATIENT 3 YEARS AFTER THE INDEX SURGERY TO ADDRESS PERSISTENT PAIN AT THE L5¿S1 SEGMENT. THE INDEX LEVEL WAS NOT DISTURBED, WITH THE TDR DEVICE LEFT INTACT. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR UNKNOWN PRODISC-L IMPLANTS, UNKNOWN PART # / LOT #. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325271 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention