BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163307 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02187
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    September 12, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-5, L5-S1 FUSION WHERE RHBMP-2 WAS MIXED WITH AUTOGRAFT AND PLACED INTO THE SPINE. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH RECURRENT SPINAL STENOSIS WITH INSTABILITY L4 TO THE SACRUM AND UNDERWENT THE FOLLOWING PROCEDURES: REVISION DECOMPRESSION L4 TO THE SACRUM. POSTEROLATERAL FUSION L4 TO THE SACRUM. POSTEROLATERAL INSTRUMENTATION L4 TO THE SACRUM. INTRAOPERATIVE EMG. LOCAL BONE GRAFT. AS PER OP-NOTES, "A MEDIAL FACETECTOMY BONE WAS COMBINED WITH BONE MORPHOGENIC PROTEIN ON A COLLAGEN CARRIER AND PACKED ACROSS THE DECORTICATED LATERAL GUTTERS FROM L4, L5 AND THE SACRAL ALA RESPECTIVELY." THE PATIENT TOLERATED THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS ALSO PRE-OPERATIVELY DIAGNOSED WITH POST LAMINECTOMY INSTABILITY, L4 TO THE SACRUM AND UNDERWENT THE FOLLOWING PROCEDURES: REVISION DECOMPRESSION, L4 TO THE SACRUM. POSTEROLATERAL FUSION, L4 TO THE SACRUM. SEGMENTAL INSTRUMENTATION, L4 TO THE SACRUM. LOCAL BONE. INTRAOPERATIVE ELECTROMYOGRAM. AS PER OP-NOTES, "THE PEDICLES WERE CANNULATED WITH AN AWL AND MALLET, AND SUBSEQUENT PROBE. THE L4 AND L5 WERE FILLED WITH 6.5 X 40-MM PEDICLE SCREWS. THE S1 SCREW WAS FILLED WITH A 35 X 40-MM PEDICLE SCREW. WITH THIS DONE, A HIGH SPEED BUR WAS USED TO DECORTICATE THE LATERAL GUTTERS. BONE MORPHOGENIC PROTEIN AND LOCAL BONE WAS THEN COMBINED, AND PACKED ACROSS THE DECORTICATED LATERAL GUTTERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264763 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111054AAA

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention