BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3171049 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02301
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    November 28, 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 THAT, ON (B)(6) 2011, PATIENT UNDERWENT FOLLOWING PROCEDURE: ANTERIOR INFERIOR OSTEOTOMY, L4-5. ANTERIOR LUMBAR INTERBODY FUSION, L4-5 AND L5-S1. PLACEMENT OF INTERBODY CAGE, L4-5 AND L5-S1. USE OF MORCELLIZED LOCAL AUTOGRAFT. USE OF RHBMP-2/ACS. PLACEMENT OF ANTERIOR INSTRUMENTATION, L4-5 AND L5-S1 (X-SPINE ANTERIOR PLATE SYSTEM) PRE-OP AND POST-OP DIAGNOSIS: TRAUMATIC DISC DISRUPTION, L4-5 AND L5-S1. RECURRENT DISC HERNIATION, LEFT L5-S1. INTRACTABLE LOW BACK PAIN. LEFT GREATER THAN RIGHT LEG PAIN PER OPERATIVE NOTES: ".. AT L4-5, SERIAL IMPLANT SIZERS WERE THEN USED AND THEN A 14MM 12 DEGREE LORDOTIC PEEK INTERBODY CAGE WAS PLACED AFTER BEING PACKED WITH AUTOGRAFT AS WELL AS RHBMP-2/ACS. PLACEMENT OF THIS CAGE WAS CONFIRMED TO BE ADEQUATE WITH AP AND LATERAL FLUOROSCOPIC IMAGING.. I WAS THEN ABLE TO COMPLETE DISCECTOMY REMOVING THE ENTIRE DISK AS WELL AS DECOMPRESSING THE L5-S1 LEVEL ANTERIORLY. THE ENDPLATES WERE PREPARED USING A BURR. THE SERIAL IMPLANT SIZERS WERE THEN USED AND THEN A 12 DEGREE LORDOTIC PEEK CAGE WAS PLACED AFTER BEING PACKED WITH AUTOGRAFT AS WELL AS RHBMP-2/ACS. THE PLACE OF THIS CAGE CONFIRMED TO BE ADEQUATE WITH AP AND LATERAL FLUOROSCOPIC IMAGING.. NO COMPLICATIONS WERE REPORTED.."

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270597 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111054AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention