BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3170738 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02290
    Event Type
    Injury
    Date Received
    June 14, 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 A PROCEDURE FOR L4-S1 ANTERIOR FUSION WHERE RHBMP-2 WAS 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 THAT ON (B)(6) 2004, PATIENT UNDERWENT FOLLOWING PROCEDURE: EXPLORATION OF ANTERIOR ARTHRODESIS L4 TO SACRUM; REMOVAL OF ANTERIOR INTERBODY INSTRUMENTATION L4 TO SACRUM; PARTIAL VERTEBRECTOMY L4, L5 AND S1 WITH ANTERIOR SPINAL DECOMPRESSION; ANTERIOR INTERBODY ARTHRODESIS L4-5 AND L5-S1; ANTERIOR SPINAL INSTRUMENTATION L4 TO S1 WITH A SYNTHES SYNEX VERTEBRAL BODY REPLACEMENT DEVICE AUGMENTED WITH CALLUS (CALCIUM PHOSPHATE BONE VOID FILLER) AND RHBMP-2 PRE-OP AND POST-OP DIAGNOSIS: STATUS ARTHRODESIS AND SEGMENTAL INSTRUMENTATION T3 TO SACRUM; STATUS VERTEBRAL OSTEOMYELITIS L4 AND L5; FAILURE OF ANTERIOR SEGMENTAL SPINAL INSTRUMENTATION WITH LUMBAR SPINE INSTABILITY; L5-S1 FORAMINAL STENOSIS SECONDARY TO INSTABILITY AND SEGMENTAL COLLAPSE AS PER OP NOTES: ".. BOTH ENDS OF THE SYNEX IMPLANT WERE FILLED WITH COLLAGEN SPONGE , WHICH HAD BEEN DOSED WITH RHBMP-2.. A LATERAL X-RAY CONFIRMED IMPLANT POSITION, OVERALL STABILITY AND ALIGNMENT APPEARED TO BE SATISFACTORY. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS PREPARED FOR SECOND PART OF THE PROCEDURE.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271949 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 00060 YR Required Intervention