BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3309136 · Received August 26, 2013

    Report

    Report Number
    1030489-2013-03660
    Event Type
    Injury
    Date Received
    August 26, 2013
    Report Date
    December 26, 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): 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.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2010, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION AT C5-6, THE INSERTION OF A SPINAL USA PEEK CAGE AT C5-6 FILLED WITH RHBMP-2/ACS, ANTERIOR CERVICAL HARDWARE REMOVAL, AND ANTERIOR CERVICAL PLATING AT C5-6 USING SPINAL USA PLATE WITH SCREWS. POST-OP, THE PATIENT RETURNED HOME, BUT HIS PAIN AND DIFFICULTIES DID NOT SUBSIDE. THE PATIENT NOW HAS CHRONIC PAIN SYNDROME, NECK PAIN, UNWANTED BONE GROWTH, CYST FORMATION, HERNIA, OBSTRUCTION OF AIRWAY, ANXIETY, AND NARCOTIC DEPENDENCE FROM PRESCRIBED PAINKILLERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417039 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