BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3520862 · Received December 16, 2013

    Report

    Report Number
    1030489-2013-05085
    Event Type
    Injury
    Date Received
    December 16, 2013
    Report Date
    November 21, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING STUDY FILMS OR PATIENT MEDICAL RECORDS 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/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 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 AN UNKNOWN DATE PATIENT PRESENTED WITH FOLLOWING COMPLICATIONS: HAS TO WALK WITH A CANE OR WALKER, SEVERE PAIN, DIZZINESS, HEADACHES, NAUSEA, VOICE CHANGED, SWELLING, TROUBLE SWALLOWING AND BREATHING, TINGLING DOWN LEGS, WEAKNESS IN L LEG. ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR SHOULDER REPAIR. ON (B)(6) 2012: THE PATIENT UNDERWENT SPINAL FUSION WITH RHBMP-2/ACS. THE SURGERY WAS IN THE REGION L3-L4 DUE TO A CAR WRECK. ON (B)(6) 2012: THE PATIENT UNDERWENT ACDF AT C6-C7 USING PHYGEN CAGE, PLATE, SCREWS, DBM, BIOD FACTOR HUMAN AMNION ALLOGRAFT. ON (B)(6) 2014: PATIENT PRESENTED WITH CERVICAL DISC/SPUR COMPLEXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655916 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