BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4782383 · Received May 19, 2015

    Report

    Report Number
    2520274-2015-13809
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIEPE, C., ET AL. (2010). THE FATE OF FACET JOINT AND ADJACENT LEVEL DISC DEGENERATION FOLLOWING TOTAL LUMBAR DISC REPLACEMENT. SPINE 35, 1991-2003. THIS REPORT IS FOR UNKNOWN PRODISC-L (POLYETHYLENE INLAY)/UNKNOWN PART AND LOT NUMBERS. UDI # UNKNOWN PART NUMBER; UDI IS UNAVAILABLE. (B)(6), (B)(4). INCIDENCE AND PROGRESSION OF ADJACENT LEVEL DEGENERATION AND FACET JOINT DEGENERATION. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: SIEPE, C., ET AL. (2010). THE FATE OF FACET JOINT AND ADJACENT LEVEL DISC DEGENERATION FOLLOWING TOTAL LUMBAR DISC REPLACEMENT. SPINE 35, 1991-2003. (GERMANY, AUSTRIA, MEXICO, RUSSIA) THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE INCIDENCE AND PROGRESSION OF ADJACENT LEVEL DEGENERATION (ALD), FACET JOINT DEGENERATION (FJD), AS WELL AS, ASSOCIATED RISK FACTORS FOLLOWING TOTAL LUMBAR DISC REPLACEMENT (TDR). ALL PATIENTS IN THIS STUDY WERE PART OF AN ONGOING PROSPECTIVE CLINICAL TRIAL WITH PRODISC-L AND WERE NONRESPONDERS TO AN INTENSIVE INPATIENT AND OUTPATIENT CONSERVATIVE TREATMENT PROGRAM CONDUCTED OVER A MINIMUM 6-MONTH PERIOD. THERE WERE 93 PATIENTS: 34 MALE, 59 FEMALE. THE AVERAGE AGE WAS 43.5 YEARS (RANGE 21.9-66.1 YEARS). CLINICAL OUTCOME SCORES VISUAL ANALOGUE SCALE (VAS), OSWESTRY DISABILITY INDEX (ODI) AND PATIENT SATISFACTION RATES WERE ACQUIRED WITHIN THE FRAMEWORK OF AN ONGOING PROSPECTIVE STUDY WITH PRODISC-L. THE MEAN INDEX-LEVEL RANGE OF MOTION (ROM) WAS ESTABLISHED FOR EVERY PATIENT OVER THE ENTIRE POSTOPERATIVE PERIOD FROM MULTIPLE FLEXION/EXTENSION X-RAY IMAGES. THE PROGRESSION OF ALD AND FJD WAS EVALUATED FROM PRE- AND POSTOPERATIVE MAGNETIC RESONANCE IMAGES BY TWO INDEPENDENT RADIOLOGISTS. THE MEAN FOLLOW-UP WAS 53.4 MONTHS (RANGE, 24.1-98.7 MONTHS). THE OVERALL RESULTS REVEALED A SIGNIFICANT IMPROVEMENT FROM PREOPERATIVE VAS AND ODI LEVELS (P < 0.0001).THE INCIDENCE OF ALD WAS 10.2% (N = 11/108 LEVELS). THE DEGENERATIVE CHANGES WERE MILD AND OCCURRED LATE AFTER SURGERY (MEAN, 65.2 MONTHS; RANGE, 37.9-85.6 MONTHS). THERE WAS NO SIGNIFICANT CORRELATION BETWEEN INDEX-LEVEL ROM AND THE OCCURRENCE OF ALD. PROGRESSION OF FJD WAS OBSERVED IN 20.0% OF ALL FACET JOINTS (N = 44/220). FJD OCCURRED SIGNIFICANTLY MORE OFTEN FOLLOWING TDR AT THE LUMBOSACRAL JUNCTION IN COMPARISON TO THE LEVEL ABOVE THE LUMBOSACRAL JUNCTION AND WAS OBSERVED MORE FREQUENTLY AT INDEX-LEVELS THAN AT NONINDEX LEVELS. THE DEGENERATIVE CHANGES WERE ASSOCIATED WITH A NEGATIVE INFLUENCE ON POSTOPERATIVE OUTCOME PARAMETERS VAS AND ODI THAT WERE ALREADY DETECTED EARLY AFTER SURGERY. THE MEAN POSTOPERATIVE ROM WAS SIGNIFICANTLY LOWER IN PATIENTS WITH PROGRESSION OF FJD IN COMPARISON TO THE REMAINING COHORT. THIS REPORT IS FOR AN UNKNOWN NUMBER OF THE PRODISC-L (POLYETHYLENE INLAY) DEVICES CONCERNING THE INCIDENCE OF ADL AND PROGRESSION OF FJD. THIS REPORT IS 3 OF 3 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326269 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention