BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4801102 · Received May 28, 2015

    Report

    Report Number
    2530088-2015-10461
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    May 1, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LITERATURE CITATION: SIEPE ET AL (2009) INTERDEPENDENCE BETWEEN DISC SPACE HEIGHT, RANGE OF MOTION AND CLINICAL OUTCOMES IN TOTAL LUMBAR DISC REPLACEMENT. SPINE (PHILA PA 1976) 34: 904-916. GERMANY, AUSTRIA, MALAYSIA, EGYPT. THIS REPORT IS FOR AN UNKNOWN PRODISC-L POLYETHYLENE INLAY WITH UNKNOWN PART AND LOT NUMBERS. (B)(4) NOT SATISFIED. 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 JOURNAL ARTICLE: SIEPE ET AL (2009) INTERDEPENDENCE BETWEEN DISC SPACE HEIGHT, RANGE OF MOTION AND CLINICAL OUTCOMES IN TOTAL LUMBAR DISC REPLACEMENT. SPINE (PHILA PA 1976) 34: 904-916. GERMANY, AUSTRIA, MALAYSIA, EGYPT. THIS WAS STUDY INCLUDING SYNTHES DEVICE, PRODISC II. THE PURPOSE OF THE STUDY WAS TO ANALYZE THE INTERACTION BETWEEN THE PARAMETERS OF DISC SPACE HEIGHT (DSH) AND RANGE OF MOTION (ROM) AND COMPARE THE RESULTS WITH CLINICAL DATA FROM AN ONGOING PROSPECTIVE CLINICAL TRIAL. THE STUDY POPULATION INCLUDED 62 PATIENTS (27 MALES, 35 FEMALES) WITH AN AVERAGE AGE OF 44.4 (RANGING 26.3-62.4 YEARS OLD). SURGERY WAS PERFORMED AT L4/5 (N=24) OR L5/S1 (N=38). AVERAGE FOLLOW-UP WAS 42.4 MONTHS WITH VISITS AT 3, 6, AND 12 MONTHS. POSTOPERATIVELY. VARIOUS PARAMETERS WERE USED TO MEASURE OUTCOMES, INCLUDING QUESTIONNAIRES. COMPLICATIONS: (N=10) AT LAST FOLLOW-UP EXAM, SUCCESS OF OPERATION RANKED ¿NOT SATISFIED.¿ SIGNIFICANT REDUCTION IN SEGMENTAL ROM. INCREASED PAIN LEVELS. THIS IS REPORT #3 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-II WITH AN UNKNOWN PART NUMBER, LOT NUMBER AND QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345606 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention