BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3172141 · Received June 17, 2013

    Report

    Report Number
    1030489-2013-02331
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    August 15, 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.

    Additional Manufacturer Narrative · 1

    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 AN L2-L5 FUSION VIA A POSTERIOR AND ANTERIOR APPROACH WHERE RHBMP-2 WAS MIXED WITH ALLOGRAFT AND IMPLANTED AT MULTIPLE LEVELS. 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) 2003 , THE PATIENT UNDERWENT: ANTERIOR TRANSPERITONEAL L3-4 AND L4-5 ANTERIOR LUMBAR INTRADISKAL FUSION; POSTERIOR OPEN EXPLORATION L2-3 FUSION, L2 TO L5 SEGMENTAL INSTRUMENTATION, L2 TO L5 POSTERIOR FUSION; PLACEMENT OF EPIDURAL CATHETER. PREOPERATIVE DIAGNOSIS: LUMBAR SPONDYLOSIS WITH BACK AND LEG PAIN. PER OP-NOTES: ¿ .. THE +2MM END PLATE REMOVALS WERE OBTAINED WITH THE LONG CHISELS. THE SURGEONS REMOVED THE REMAINING DISC MATERIAL WITH CUP CURETS AND THEN IMPACTED A 16MM GRAFT THAT WAS FILLED WITH A MIXTURE OF RHBMP-2 AND CANCELLOUS ALLOGRAFT. THEY THEN IMPACTED INTO THE DISC SPACE¿..THE CORE OF THIS WAS FILLED WITH A MIXTURE OF CANCELLOUS ALLOGRAFT AND BMP . BMP SLABS AND CANCELLOUS ALLOGRAFT WERE THEN PLACED ANTERIORLY AND ANTEROLATERALLY OVER THE GRAFT AND OUR CHANNEL WAS REMOVED¿.THE SURGEONS THEN PLACED A MIXTURE OF SHREDDED BMP WITH CANCELLOUS ALLOGRAFT AND AUTOGRAFT OVER OUR LAMINAR ARCHES FROM L2 TO L5 FOR MIDLINE POSTERIOR FUSION PURPOSES. A SINGLE CROSS CONNECTOR WAS PLACED ACROSS THE RODS BETWEEN THE L3 AND L4 PEDICLE SCREWS. THIS WAS SECURED IN PLACE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273242 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention