BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 3771265 · Received April 24, 2014

    Report

    Report Number
    2530088-2014-10062
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FOR 1 UNKNOWN PRODISC-C, UNKNOWN PART#/LOT#. IMPLANT DATE: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REPORTS IS BEING FILED AFTER SUBSEQUENT REVIEW OF AN ABSTRACT OF A ORAL PRESENTATION IN THE 17TH ARGOSPINE SYMPOSIUM SCIENTIFIC BOOK: "BALL AND SOCKET SEMICONSTRAINED CERVICAL DISC REPLACEMENT. A PROSPECTIVE CLINICAL AND RADIOLOGICAL COMPARISON OF TWO DESIGNS. -ELY ASHKENAZI." A CLINICAL AND RADIOLOGICAL STUDY OF 65 PATIENTS WHO UNDERWENT TOTAL CERVICAL DISC REPLACEMENT (TDR) WITH THE PRESTIGE DISC (30 PATIENTS) AND WITH THE PRODISC-C (35 PATIENTS). RANGE OF MOTION IN THE SAGITTAL PLANE AND PAIN ON THE VISUAL ANALOG SCALE (VAS) BEFORE AND AFTER THE OPERATION WERE STUDIED. RANGE OF MOTION WAS INVESTIGATED IN 20 PATIENTS WHO UNDERWENT TDR WITH THE PRESTIGE DISC AND IN 26 PATIENTS WITH THE PRODISC-C. FORTY NINE (49) PATIENTS OUT OF THE 65 PATIENTS WERE AVAILABLE FOR FOLLOW-UP, PATIENTS WERE FOLLOWED BETWEEN 24-60 MONTHS. NO BONE OR INSTRUMENTATION FAILURE WAS RECORDED IN THE PRESTIGE GROUP. IN 14 % OF THE PRODISC GROUP INSTRUMENTATION AND BONE FAILURE WERE IDENTIFIED. TWO CASES OF SPLIT FRACTURE OF THE VERTEBRAL BODY, 2 CASES OF POSTERIOR VERTEBRAL WALL FRACTURE AND ONE CASE OF PROSTHESIS DISLOCATION. THE VAS WAS ADMINISTERED TO ALL PATIENTS PRIOR TO OPERATION AND AT ALL ROUTINE FOLLOW-UP VISITS. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT FOR UNKNOWN PRODISC-C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248985 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention