BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2763366 · Received September 27, 2012

    Report

    Report Number
    1030489-2012-01729
    Event Type
    Injury
    Date Received
    September 27, 2012
    Report Date
    August 29, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOSIS WITH DISC HERNIATION C4-5 AND C5-6. THE PATIENT UNDERWENT AN ACDF C4-5-6 WITH INTERNAL FIXATION USING RBI PLATES AND ACROMED ALLOGRAFT BONE. THERE IS NO MENTION OF BMP IN THE OPERATIVE NOTES PROVIDED. AT 1390 DAYS POST-OP, THE PATIENT PRESENTED WITH A HERNIATED CERVICAL DISC AT C6-C7 WITH RADICULOPATHY. THE PATIENT UNDERWENT A TOTAL DISCECTOMY AT C6-7, REMOVAL OF OSTEOPHYTES AND ANTERIOR CERVICAL FUSION USING A RABEA CAGE. NO INSTRUMENTATION WAS UTILIZED AND THERE IS NO MENTION OF BMP IN THE OPERATIVE NOTES PROVIDED. PER THE OP NOTE, "WE PLACED SOME BONE SUBSTITUTE ANTERIOR TO THE CAGE." IT IS ALLEGED THAT THE PATIENT RECEIVED BMP, AND FURTHER, THAT THE PATIENT HAS DEVELOPED NUMBNESS ON THE ENTIRE LEFT SIDE, CONSTANT TINGLING, NECK PAIN, MUSCLE, CHEST AND ARM SPASMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention