BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3923677 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03176
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A CERVICAL DISCECTOMY, FUSION, CAGE INSERTION, WITH ANTERIOR CERVICAL INSTRUMENTATION AT C4-7. ON (B)(6) 2010, THE PATIENT UNDERWENT AN AXIALIF POSTERIOR AT L5-S1 USING RHBMP-2/ACS . SOMETIME POSTOP, THE PATIENT REPORTEDLY DEVELOPED NEW PAIN IN HER NECK, SHOULDERS, AND THE BACK OF HER HEAD. THE PATIENT REPORTS THAT SHE "CANNOT LIFT ANYTHING BECAUSE OF HER ARM, NECK, AND BACK PAIN, AND HAS DIFFICULTY SITTING OR STANDING FOR EXTENDED PERIODS." THE PATIENT CONTINUED TREATING WITH THE DOCTOR UNTIL (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE FALL OF 2010, THE PATIENT EXPERIENCED LOW BACK PAIN. IN THE SURGERY ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. AFTER THIS SURGERY, THE PATIENT DEVELOPED NEW PAIN IN HER NECK, SHOULDERS, AND THE BACK OF HER HEAD. POST THE SECOND SURGERY ON (B)(6) 2010, THE PATIENT CONTINUED TREATING WITH THE SAME SURGEON UNTIL (B)(6) 2011. SHE IS PHYSICALLY LIMITED IN NEARLY EVERYTHING SHE DOES. SHE CONTINUES EXPERIENCING THE PAIN SHE EXPERIENCED BEFORE, BUT WITH GREATER SEVERITY. ADDITIONALLY, HER PAIN IS EXTENSIVE. SHE CANNOT LIFT ANYTHING BECAUSE OF HER ARM, NECK, AND BACK PAIN, AND HAS DIFFICULTY SITTING OR STANDING FOR EXTENDED PERIODS. THE PATIENT WAS IMPLANTED RHBMP-2/ACS WITH A POSTERIOR APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399710 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