BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3170909 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02292
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    August 29, 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 A PROCEDURE FOR ANTERIOR L3-S1 FUSION 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) 2009: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L3-L4 TO L5-S1 DISC DEGENERATION WITH L4-L5 RETROLISTHESIS AND UNDERWENT THE FOLLOWING PROCEDURES: L3-L4, L4-L5 AND L5-S1 ANTERIOR LUMBAR INTERBODY FUSION WITH INSTRUMENTATION. L3-L4, L4-L5 AND L5-S1 BILATERAL POSTEROLATERAL FUSION WITH L3-S1 SEGMENTAL INSTRUMENTATION; PLACEMENT OF EPIDURAL CATHETER. AS PER OP-NOTES, "I ULTIMATELY SELECTED A TRIAL SPACER WITH 10 DEGREES OF LORDOSIS, 14 MM IN HEIGHT, 30 MM IN DEPTH AND 33 MM IN WIDTH FOR THE L3-L4 SPACE. THIS PEEK GRAFT WAS OBTAINED AND FILLED WITH A MIXTURE OF RHBMP-2 AND CANCELLOUS ALLOGRAFT BONE CHIPS. SMALL STRIPS OF RHBMP-2 AND MORSELIZED CANCELLOUS ALLOGRAFT WERE PLACED IN THE POSTERIOR ASPECT OF THE DISK SPACE. OUR PEEK GRAFT WAS THEN IMPACTED INTO THE DISC SPACE. SAME PROCEDURE WAS REPEATED AT L4-L5 AND L5-S1 DISC. AT L5-S1 LEVEL A 14MM HEIGHT, 10 DEGREE LORDOTIC ANGLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270936 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110810AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention