BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3922646 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03160
    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)(6).

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE AT MULTIPLES LEVELS USING RHBMP-2/ACS ON (B)(6) 2008. FOLLOWING THE SURGERY, PATIENT AWOKE IN SEVERE PAIN AND WAS UNABLE TO LIE DOWN COMPLETELY. WITHIN A YEAR, PATIENT BEGAN TO SUFFER PAIN AND NUMBNESS IN HER RIGHT LEG AND HIP, AND WAS UNABLE TO RETURN TO SCHOOL FOR THREE MONTHS. AFTER SEVERAL UNSUCCESSFUL INJECTIONS, PATIENT UNDERWENT A SPINAL FUSION WITH THE INSTALLATION OF HARDWARE AT S1 ON (B)(6) 2009. SINCE THE SURGERY, PATIENT HAS BEGUN TO SUFFER FROM NEW PAIN IN HER SHOULDER AND COLLARBONES.

    Description of Event or Problem · 1

    IN EARLY 2007, PATIENT WAS DIAGNOSED WITH KYPHOSIS. ON (B)(6) 2008, THE PATIENT UNDERWENT A FUSION OF THE THORACIC SPINE WITH HARDWARE INSTALLATION AT MULTIPLES LEVELS. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS AND PEEK CAGE. PATIENT WAS MINOR AT THE TIME OF SURGERY, ONLY (B)(6). POST-OP, PATIENT WAS UNABLE TO RETURN TO SCHOOL FOR THREE MONTHS. WITH IN A YEAR, PATIENT BEGAN TO SUFFER PAIN AND NUMBNESS IN HER RIGHT LEG AND HIP. PATIENT ALSO UNDERWENT FOR SEVERAL INJECTIONS DUE TO HER PAIN. ON (B)(6) 2009, PATIENT UNDERWENT SURGERY OF AN S1 SPINAL FUSION WITH THE INSTALLATION OF HARDWARE. POST-OP, SINCE LAST SURGERY PATIENT BEGUN TO SUFFER FROM NEW PAIN IN HER SHOULDER AND COLLARBONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401090 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 00016 YR Other| R