BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 5979350 · Received September 27, 2016

    Report

    Report Number
    2520274-2016-14691
    Event Type
    Injury
    Date Received
    September 27, 2016
    Report Date
    August 29, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PARK, S., ET AL (2016). LONG-TERM OUTCOMES FOLLOWING LUMBAR TOTAL DISC REPLACEMENT USING PRODISC-II. SPINE OUTCOMES, VOLUME 41, NUMBER 11, PP. 971-977. THIS REPORT IS FOR AN UNKNOWN PRODISC II DEVICE (POLYETHYLENE INLAY), UNKNOWN QUANTITY, UNKNOWN LOT. PRODUCT CODE: MJO. UDI #: UNKNOWN PART NUMBER, UDI UNAVAILABLE. (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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: PARK, S., ET AL (2016). LONG-TERM OUTCOMES FOLLOWING LUMBAR TOTAL DISC REPLACEMENT USING PRODISC-II. SPINE OUTCOMES, VOLUME 41, NUMBER 11, PP. 971-977. SOUTH KOREA. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE LONG-TERM CLINICAL AND RADIOGRAPHIC OUTCOMES AND TO INVESTIGATE WHO ACHIEVED THE SUCCESSFUL OUTCOMES AFTER LUMBAR TOTAL DISC REPLACEMENT (TDR) USING PRODISC II. THE STUDY WAS COMPLETED BETWEEN MARCH 2002 AND FEBRUARY 2007 AND CONSISTED OF 54 PATIENTS (36 FEMALES, 18 MALES) WITH A MEAN AGE OF 44.1 YEARS (RANGE, 23-59). THE FOLLOWING COMPLICATIONS WERE REPORTED: ONE PATIENT REQUIRED REVISION SURGERY DUE TO DEGENERATIVE SPONDYLOLISTHESIS. THIS IS REPORT 2 OF 9 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC II DEVICE (POLYETHYLENE INLAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632092 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention