BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4723843 · Received April 23, 2015

    Report

    Report Number
    2530088-2015-10121
    Event Type
    Injury
    Date Received
    April 23, 2015
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN PRODISC-C/ UNKNOWN QUANTITY/ UNKNOWN LOT. (B)(4). 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 SUBSEQUENT REVIEW OF THE FOLLOWING ABSTRACT: YI, S AND ET AL (2014):THE FATE OF HETEROTOPIC OSSIFICATION ASSOCIATED WITH CERVICAL ARTIFICIAL DISC REPLACEMENT. SPINE, VOLUME 39, NUMBER 25, 2078-2083. SIXTY-SEVEN PATIENTS UNDERWENT CERVICAL DISC ARTHROPLASTY SINCE DECEMBER 2003 AND WHO HAD A FOLLOW-UP DURATION THAT WAS LONGER THAN 12 MONTHS WERE SELECTED FOR THIS STUDY. THIS PATIENT GROUP HAD BEEN ENROLLED FOR A RETROSPECTIVE OBSERVATIONAL STUDY OF HETEROTOPIC OSSIFICATION (HO) OCCURRENCE FROM 2003 TO 2007. FORTY-SIX OF THE SUBJECTS WERE MALE AND TWENTY-ONE WERE FEMALE. THE MEAN AGE WAS 43.5 YEARS (RANGE, FOURTEEN TO SIXTY-SIX YEARS). THE MEAN FOLLOW-UP PERIOD FOR THE FIRST STUDY WAS 18.6 MONTHS (RANGE, 10.2 TO 53.9 MONTHS). THE MEAN FOLLOW-UP PERIOD FOR THE SECOND STUDY WAS 36.9 MONTHS (RANGE, 22.9 TO 76.6 MONTHS). FIFTY PATIENTS WERE IMPLANTED WITH COMPETITOR'S DEVICE AND SEVENTEEN WERE IMPLANTED WITH A PRODISC-C. AMONG THE 67 PATIENTS IN THIS STUDY, 31 PATIENTS SHOWED HO OCCURRENCE (46.3%) AT THE FIRST FOLLOW-UP TIME POINT. AT THE TIME OF THE SECOND FOLLOW-UP TIME POINT, HO WAS FOUND IN 43 OF 67 PATIENTS (64.2%). THE HO OCCURRENCE RATE INCREASED BY 17.9% IN THE SELECTED PATIENT GROUP. IN THIS STUDY, 26 OF 67 PATIENTS (39.4%) PROGRESSED TO A HIGHER HO GRADE BUT 41 PATIENTS (60.6%) HAD NO CHANGE IN HO GRADE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-C CONSTRUCT, UNKNOWN PART#/LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270208 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention