BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2961914 · Received February 14, 2013

    Report

    Report Number
    1030489-2013-00481
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "SERIOUS PAIN, PHYSICAL LIMITATIONS, HAS REQUIRED [PATIENT] TO UNDERGO A REVISION SURGERY. [PATIENT] WORRIED THINGS WILL NEVER GET BETTER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "SERIOUS PAIN, PHYSICAL LIMITATIONS, HAS REQUIRED [PATIENT] TO UNDERGO A REVISION SURGERY. [PATIENT] WORRIED THINGS WILL NEVER GET BETTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65432 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