BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4788978 · Received May 21, 2015

    Report

    Report Number
    2530088-2015-10345
    Event Type
    Injury
    Date Received
    May 21, 2015
    Report Date
    May 4, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS YI S, OH J, HA Y, KIM K , YOON D, 2011. TRANSITIONAL APPEARANCE OF ADVANCED HETEROTOPIC OSSIFICATION IN CERVICAL ARTIFICIAL DISC REPLACEMENT, THE SPINE JOURNAL, 11, 2011, SOUTH KOREA. THIS REPORT IS FOR UNKNOWN PRODISC-C IMPLANT. UDI # UNKNOWN PART AND LOT NUMBER, UDI IS UNAVAILABLE. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT 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 ABSTRACT: YI S, OH J, HA Y, KIM K , YOON D, 2011. TRANSITIONAL APPEARANCE OF ADVANCED HETEROTOPIC OSSIFICATION IN CERVICAL ARTIFICIAL DISC REPLACEMENT, THE SPINE JOURNAL, 11, 2011, SOUTH KOREA. THIS RETROSPECTIVE CLINICAL STUDY WAS DESIGNED TO INVESTIGATE THE TRANSITIONAL APPEARANCE OF HETEROTOPIC OSSIFICATION FROM THE MID-TERM OBSERVATIONAL STUDY OF HETEROTOPIC OSSIFICATION AND TO UNDERSTAND NATURAL COURSE OF HETEROTOPIC OSSIFICATION. DETERMINATION OF HETEROTOPIC OSSIFICATION USED POSTOPERATIVE RADIOGRAPHS AND CT SCANS. A TOTAL OF 67 PATIENTS UNDERGOING CERVICAL ARTHROPLASTY IN THREE GROUPS, 2 GROUPS WITH NON-SYNTHES IMPLANTS, AND ONE GROUP OF 17 PRODISC -C PATIENTS. COMPLICATIONS: OVERALL HETEROTOPIC OSSIFICATION RATE WAS IN 31 OF 67 PATIENTS WITH PRODISC-C AT 64.7%. THIS INCLUDES MIDTERM AND FINAL HETEROTOPIC OSSIFICATION RATES. IT MAY ALSO INCLUDE THE OVERALL NEW OCCURRENCE RATE OF 33.3% FOR PRODISC-C. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR PRODISC-C WITH UNKNOWN PART NUMBERS, LOT NUMBERS AND QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331047 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention