BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3923085 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03169
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT WAS OPERATED AT THE L2 AND L5 LEVELS, UNDERGOING A SPINAL FUSION AND DISECTOMY, USING INSTRUMENTATION AND INSERTING A LUMBAR CAGE. REPORTEDLY, RHBMP-2/ACS WAS USED IN THE SURGERY. AFTER HER SURGERY, THE PATIENT EXPERIENCED LOW PAIN THAT WAS MUCH WORSE THAN THE PAIN SHE HAD EXPERIENCED PRIOR TO SURGERY. THE PATIENT IS ON TOO MUCH PAIN MEDICATION TO FUNCTION PROPERLY AT WORK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT A POSTERIOR APPROACH SPINE SURGERY AND DISCECTOMY-- MULTIPLE LEVEL, T SPINE WITH PEEK CAGE AT L2¿5. DURING THIS SURGERY RHBMP-2/ACS WAS USED. SOMETIME POSTOP, THE PATIENT EXPERIENCED SEVERE PAIN. THE PATIENT CONTINUED TREATING WITH THE SURGEON AND HAD PHYSICAL THERAPY. THE PATIENT CONTINUED TREATING WITH THE SURGEON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400642 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| R