BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE

    MDR report key: 1368930 · Received April 24, 2009

    Report

    Report Number
    2530088-2009-00088
    Event Type
    Injury
    Date Received
    April 24, 2009
    Date of Event
    April 9, 2009
    Report Date
    April 9, 2009
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PRODISC-C IMPLANTED FOR DDD AT C4-C5. ACCORDING TO THE CT SCAN, THE FINAL IMPLANT POSITION APPEARED TO BE PROPERLY PLACED. PT WAS AWAKENED AFTER SURGERY AND COULD NOT FEEL ANY SENSATION IN HIS ARMS AND LEGS. THE SURGEON REMOVED PRODISC-C TO COMPLETE A MORE THOROUGH DECOMPRESSION AND DISCECTOMY. SURGEON FUSED PT WITH AN ANTERIOR CERVICAL PLATE AND ALLOGRAFT BONE SPACER. ONE DAY POSTOP, SURGEON KEPT PT INTUBATED AND TOOK AN MRI. MRI SHOWED A PIECE OF THE OSSIFIED PLL HAD BEEN LEFT BEHIND AFTER THE ORIGINAL SURGERY AND HAS PROTRUDED INTO THE CANAL IMPINGING ON THE SPINAL CORD. THE PLATE, BONE SPACER AND THE PIECE OF OSSIFIED PLL WERE REMOVED. THE PLATE AND BONE SPACER WERE RE-IMPLANTED. FOUR DAYS POSTOP, PT REGAINED SENSATION IN HIS HANDS AND FEET, BUT UNABLE TO MOVE UPPER AND LOWER EXTREMITIES. PT'S SPINAL CORD APPEARS TO BE DAMAGED AT THE C5 LEVEL. SURGEON PLANS TO TAKE ANOTHER MRI. FIFTEEN DAYS POST OP PT'S STATUS REMAINS THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT LARGE PRODISC-C IMPLANT MJO SYNTHES BRANDYWINE NA 5820990

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention