BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 3823823 · Received May 21, 2014

    Report

    Report Number
    2530088-2014-10125
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE UNKNOWN POLYETHYLENE INLAY/UNKNOWN LOT. IMPLANT DATE: UNKNOWN DATE IN 2008. DEVICE HAS NOT BEEN EXPLANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    FOUR X-RAY IMAGES WERE RECEIVED THAT REASONABLY SUGGEST A REVISION WAS PERFORMED ON A PATIENT IMPLANTED WITH A PRODISC-L. LATERAL IMAGES WERE TAKEN DURING THE PROCEDURE AND AN UNKNOWN ARTIFACT OF SOME TYPE IS APPEARING IN ONE OF THE IMAGES AT THE ANTERIOR MARGIN OF THE INFERIOR PRODISC-L PLATE. THE PATIENT UNDERWENT A TOTAL DISC REPLACEMENT WITH AN UNKNOWN PRODISC-L AT L3-4 ON AN UNKNOWN DATE IN 2008. THE PATIENT IS ALSO IMPLANTED WITH AN UNKNOWN INTERBODY DEVICE AT AN ADJACENT LEVEL. ON TUESDAY, (B)(6) 2014, THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND WAS IMPLANTED WITH PEDICLE SCREWS AND RODS WHICH WERE PLACED POSTERIORLY AT ADJACENT LEVELS. THE PRODISC-L DEVICE WAS LEFT INTACT. THIS REPORT IS FOR ONE UNKNOWN POLYETHYLENE INLAY. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE REVISION WAS DUE TO PAIN. THE PATIENT WAS REVISED TO A COMPETITOR'S POSTERIOR INSTRUMENTATION. IT WAS ALSO REPORTED PER MEDICAL DIRECTOR REVIEW OF IMAGES ON 06/17/2014 THAT ALL FOUR IMAGES ARE LATERAL VIEWS OF LUMBAR SPINE. IT APPEARS A METAL PART AT THE ANTERIOR MARGIN OF THE INFERIOR PRODISC-L PLATE IS PROTRUDING OR BENDING DOWNWARD. IT'S NOT CLEAR IF IT IS PART OF THE PRODISC-L OR FROM ANOTHER SOURCE. THERE IS A POSSIBLE FRACTURE AT THE SUPERIOR-ANTERIOR CORNER OF THE L4 VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302727 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention