BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELAMON® FUSION DEVICE

    MDR report key: 6371107 · Received March 2, 2017

    Report

    Report Number
    1030489-2017-00445
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 5, 2017
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO THE REPORTED EVENT WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES ONLY.

    Description of Event or Problem · 1

    LEVELS: T9-L3 IT WAS REPORTED THAT PATIENT BURST FRACTURE(TH12 AND L1) UNDERWENT OSTEOTOMY, POSTERIOR SPINAL FUSION AND CORRECTION OF KYPHOSIS. DURING THE SURGERY, SPACERS WERE PLACED IN THE PART WHERE OSTEOTOMY WAS PERFORMED. NUVASIVE, INC.¿S SCREW (RELINE)+MOTOR-EVOKED POTENTIALS (MEP) WERE ALSO USED. AFTER INSERTION OF SCREW, THE SURGEON PERFORMED OSTEOTOMY. WHEN HE ATTEMPTED TO CONDUCT CORRECTION AFTER PLACING SPACERS, MOTOR-EVOKED POTENTIALS WERE NOT RESPONDING CORRECTLY. THE SURGEON ADJUSTED IT LOTS OF TIMES BUT FINALLY, LOWER EXTREMITY PARALYSIS OCCURRED NEXT DAY. ADDITIONALLY, IT WAS REPORTED THAT ON (B)(6) 2017, POST-OP, PARALYSIS WAS REMAINING IN THE PATIENT¿S LOWER EXTREMITY. THERE IS NO PLAN TO REMOVE IMPLANTS NOW BUT IT IS UNKNOWN WHAT SUPPORT WILL BE NEEDED IN THE FUTURE. NO DEVIATION OF SPACERS WAS OBSERVED. ACCORDING TO THE HEALTHCARE PROFESSIONAL'S OPINION, THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE USE OF PRODUCT IS UNKNOWN BUT THIS EVENT CAN RESULT IN ANY CONGENITAL DISEASE OR ANOMALY IN THE OFFSPRING OF THE TREATED PATIENT. AS A RESULT OF PARALYSIS, THE DAY AFTER THE SURGERY, DECOMPRESSION WAS ADDED AND THE ROD CORRECTION WAS RELIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156614 TELAMON® FUSION DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA VS55

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention