BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3143523 · Received June 3, 2013

    Report

    Report Number
    1030489-2013-02069
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    December 5, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM A SPINAL FUSION SURGERY USING RHBMP-2/ACS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2009 THE PATIENT UNDERWENT A C4-C5 ANTERIOR CERVICAL DISCECTOMY AND ARTHRODESIS WITH STRUCTURAL ALLOGRAFT AND ANTERIOR INSTRUMENTATION USING THE OPERATING MICROSCOPE. IT WAS REPORTED THAT AS A RESULT OF THIS SURGERY USING INFUSE THE PATIENT NOW SUFFERS FROM CHRONIC PAIN SYNDROME, NECK PAIN, SUBOCCIPITAL HEADACHES, AND NARCOTIC DEPENDENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A C4-5 ANTERIOR CERVICAL DISCECTOMY AND ARTHRODESIS WITH STRUCTURAL ALLOGRAFT AND ANTERIOR INSTRUMENTATION USING THE OPERATING MICROSCOPE. THE PATIENT LATER RETURNED HOME, BUT HER PAIN AND DIFFICULTIES DID NOT SUBSIDE. PATIENT DEVELOPED CHRONIC PAIN SYNDROME, NECK PAIN, SUBOCCIPITAL HEADACHES, AND NARCOTIC DEPENDENCE FROM PRESCRIBED PAINKILLERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243450 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 Other