BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-07849

    MDR report key: 3525240 · Received December 18, 2013

    Report

    Report Number
    2520274-2013-07849
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    November 22, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODISC-C TOTAL DISC REPLACEMENT. A FOUR-YEAR PROSPECTIVE MONOCENTRIC STUDY; BARNA M., STULIK J., KRYL J., VYSKOCIL T., NESNIDAL P.; ACTA CHIRURGIAE ORTHOPAEDICAE ET TRAUMATOLOGIAE CECHOSLOVACA (2012) 79 (6) (PP 512-519). THIS REPORT IS FOR ONE UNKNOWN PRODISC-C. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    JOURNAL ABSTRACT RECEIVED: PRODISC-C TOTAL DISC REPLACEMENT. A FOUR-YEAR PROSPECTIVE MONOCENTRIC STUDY; BARNA M., STULIK J., KRYL J., VYSKOCIL T., NESNIDAL P.; ACTA CHIRURGIAE ORTHOPAEDICAE ET TRAUMATOLOGIAE CECHOSLOVACA (2012) 79 (6) (PP 512-519); REPORTED: THE RESULTS OF AN INDEPENDENT PROSPECTIVE MONOCENTRIC STUDY OF 61 PATIENTS WHO UNDERWENT PRODISC-C (SYNTHES, USA) TOTAL DISC REPLACEMENT (CTDR) INVOLVING ONE OR TWO SEGMENTS. THIRTY NINE PATIENTS WITH PRODISC-C CTDR WERE FOLLOWED UP FOR AT LEAST 4 YEARS. IN ADDITION, THE MOST FREQUENT LATE COMPLICATIONS WERE ANALYZED. THE PATIENTS WERE EXAMINED BEFORE SURGERY, IMMEDIATELY AFTER IT AND AT 6 AND 12 WEEKS AND 6, 12, 24 AND 48 MONTHS POST-OPERATIVELY. CLINICAL RESULTS INCLUDED: HETEROTOPIC OSSIFICATION IN 10 TREATED DISCS, FIVE OF WHICH WERE CLASSIFIED AS GRADE III OR IV; SPONTANEOUS FUSION ACROSS THE DISC REPLACEMENT LEVEL IN THREE CASES; AND THE DEVELOPMENT OF KYPHOSIS AT THE AFFECTED DISC LEVEL IN TWO PATIENTS. IN CONCLUSION, THE AUTHORS NOTED THAT HETEROTOPIC OSSIFICATION WAS THE MOST FREQUENT LATE COMPLICATION OF CTDR. MANY FACTORS COULD BE RELATED TO ITS DEVELOPMENT, THEREFORE PREVENTION WAS NOT CLEAR. THE CORRECT INDICATION AND APPROPRIATE SURGICAL TECHNIQUE WERE THE MOST FREQUENTLY RECOMMENDED PREVENTATIVE MEASURES, AND WERE ALSO CONSIDERED BY THE AUTHORS TO BE THE MOST IMPORTANT. THIS REPORT IS FOR ONE UNKNOWN PRODISC-C. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663039 MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1