BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4851614 · Received June 17, 2015

    Report

    Report Number
    2520274-2015-14495
    Event Type
    Injury
    Date Received
    June 17, 2015
    Report Date
    June 3, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AN INTERNAL REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: FROM ALL THREE IMAGES, LOOKS LIKE A STAND-ALONE INTERVERTEBRAL SPACER WITH FOUR SCREWS WAS IMPLANTED AT L51S1 LEVEL AND A PRODISC L ARTIFICIAL DISC WAS IMPLANTED AT L4/5 LEVEL. BY COMPARING THE POSITIONS OF THE ENDPLATES AND THE X-RAY MARKER, AND THE SPACE BETWEEN THE TWO DISC PLATES, THERE IS NO SIGNIFICANT EVIDENCE TO CONCLUDE THE POSITION CHANGE OF ANY COMPONENT OF THE ARTIFICIAL DISC. IT APPEARS THAT TWO ENDPLATES ARE NOT VERY PARALLEL WITH EACH OTHER ON AP VIEW, HOWEVER NO CONCLUSION CAN BE MADE. 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. PATIENT INFORMATION NOT PROVIDED BY REPORTED. DATE UNKNOWN WHEN PAIN ACTUALLY ORIGINATED OR WHEN CREPITATION FIRST STARTED. THIS REPORT IS FOR ONE UNKNOWN - PDL SUPERIOR PLATE IMPLANT/UNKNOWN LOT NUMBER. ORIGINAL IMPLANT DATE IS UNKNOWN. NOT EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND 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

    IT WAS REPORTED BY THE SURGEON THAT APPROXIMATELY TEN DAYS POSTOPERATIVE, WHILE THE PATIENT WAS WALKING HE DESCRIBED TO THE SURGEON HEARING AND FEELING CREPITATION WITH ACUTE SHARP PAIN WHICH RESOLVED. OVERALL, PATIENT IS MARKEDLY IMPROVED SUBJECTIVELY AND OBJECTIVELY VS PREOP, INCLUDING BACK AND LOWER EXTREMITY COMPLAINTS. SURGEON ALSO REPORTED THAT THE HOSPITAL RADIOLOGIST IS UNABLE TO COMMIT ON WHETHER OR NOT SPACER HAS MIGRATED AND COLLAPSED. SURGEON IS CONCERNED THAT THERE IS INSTABILITY DUE TO POSSIBLE PARTIAL EXTRUSION OF POLYETHYLENE DOME FROM SUPERIOR L5 PROSTHETIC METALLIC ENDPLATE. X-RAYS SHOW THAT THE PDL WAS IMPLANT AT THE L4-L5 LEVEL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395205 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention