BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3594964 · Received January 28, 2014

    Report

    Report Number
    1030489-2014-00240
    Event Type
    Injury
    Date Received
    January 28, 2014
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS OF LUMBAR STENOSIS, L4-L5, WITH INTRACTABLE BACK AND LEG PAIN. THE PATIENT UNDERWENT DECOMPRESSIVE LUMBAR LAMINECTOMY, L4 AND L5, BILATERAL, WITH FORAMINOTOMIES FROM L3 THROUGH S1 AND A BMP LATERAL MASS FUSION, L4, L5 AND S1 PROCEDURES. INDICATIONS: THE PATIENT HAS HAD PROBLEMS WITH SEVERE PAIN IN HIS BACK AND PAIN IN HIS IOWER EXTREMITIES WHICH HAS BEEN PROBLEMATIC AND DISABLING. PER OP NOTES, THE SURGEON DECORTICATED THE LATERAL MASSES AT L4, L5 AND S1, THEN USED BONE CUTTER, DOUBLE-ACTION RONGEUR, DRILL AND KERRISON RONGEUR TO COMPLETE THE DECOMPRESSIVE LUMBAR LAMINECTOMY AT L4 AND L5. THE AREA WAS WELL DECOMPRESSED. THE FORAMINOTOMY WAS COMPLETED FOR THE EXITING L3 THROUGH S1 NERVE ROOTS BILATERALLY. THE SURGEON THEN THOROUGHLY IRRIGATED. ALL THE BLEEDING POINTS WERE CONTROLLED. THE SURGEON THEN USED THE AUTOGRAFT BONE AND MIXED IT WITH BMP TO COMPLETE THE LATERAL MASS FUSION AT THE L4 THROUGH S1 LEVEL BILATERALLY, WHICH WAS THOROUGHLY IRRIGATED. ALL THE BLEEDING POINTS WERE CONTROLLED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO PATIENT COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61288 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110809AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other