BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4777791 · Received May 18, 2015

    Report

    Report Number
    2530088-2015-10349
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: LEE C, CHUNG S, OH S , YOU J. MAY 2011 SIGNIFICANCE OF ANGULAR MISMATCH BETWEEN VERTEBRAL ENDPLATE IN LUMBAR TOTAL DISC REPLACEMENT. J SPINAL DISORDER TECH, 24:183-188. KOREA. THIS REPORT IS FOR UNKNOWN PRODISC-L IMPLANT, PDL INLAY. 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 JOURNAL ARTICLE: LEE C, CHUNG S, OH S , YOU J. MAY 2011 SIGNIFICANCE OF ANGULAR MISMATCH BETWEEN VERTEBRAL ENDPLATE IN LUMBAR TOTAL DISC REPLACEMENT. J SPINAL DISORDER TECH, 24:183-188. KOREA FROM JUNE 2002 TO FEBRUARY 2006 56 PATIENTS (33 FEMALES AND 23 MALES, AVERAGE AGE OF 44.7 YEARS) UNDERWENT TOTAL DISC REPLACEMENT WITH PRODISC-L THE MEAN FOLLOW UP PERIOD WAS 25.6 MONTHS. RADIOGRAPHIC EVALUATIONS AND VARIOUS OTHER ASSESSMENT TOOLS WERE UTILIZED AT ONE WEEK, 6 WEEKS, 6 MONTHS AND ONE YEAR AFTER OPERATION. COMPLICATIONS: TWO PATIENTS EXPERIENCED SUBSIDENCE AT L4-L5. THREE PATIENTS EXPERIENCED SUBSIDENCE AT L5 S1. THIS REPORT 2 OF 6 FOR COM-(B)(4). THIS REPORT IS FOR A PRODISC-L WITH AN UNKNOWN PART NUMBER, LOT NUMBER AND QUANTITY IMAGES INCLUDED IN ARTICLE, DATES UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322286 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1