BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3162943 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02161
    Event Type
    Injury
    Date Received
    June 11, 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.

    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-L5 TLIF WHERE RHBMP-2 WAS MIXED WITH AUTOGRAFT AND IMPLANTED WITH AN INTERBODY CAGE. 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 PER PATIENT¿S MEDICAL RECORDS THAT ON: (B)(6) 2010: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSES: SPONDYLOLISTHESIS L4-L5. BILATERAL PARS DEFECT WITH SEVERE FORAMINAL STENOSIS. SHE UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR SPINAL FUSION L4-L5. POSTERIOR SPINAL INSTRUMENTATION SYSTEM L4-L5. TLIF L4-L5. INTERBODY DEVICE PLACEMENT L4-L5. LOCAL BONE GRAFT WITH RHBMP-2 PLACEMENT. PER SURGEON¿S OP NOTES, ¿THE DISC WAS THEN TAKEN OUT AND VERY TIGHT AND THROUGH A SERIES OF TRIALS WE CLEANED THIS UP, REMOVED THE DISC. I THEN PACKED THIS WITH RHBMP-2 AND CANCELLOUS BONE. FROM THAT STANDPOINT A INTERBODY DEVICE CAGE WAS THEN PLACED. THE RODS WERE CONTOURED, TIGHTENED AND THEN LOCKED INTO PLACE. INTRAOPERATIVE FILMS SHOWED GOOD ALIGNMENT AND GOOD FIXATION.¿ NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262713 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110811AAM

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention