BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3171008 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02299
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    November 14, 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 FUSION WHERE RHBMP-2 WAS IMPLANTED WITH A PEEK CAGE AND PEDICLE SCREW FIXATION. 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) 2008: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: L4-L5 DISK HERNIATION, FACET ARTHROPATHY, BILATERAL FORAMINAL NARROWING AND NERVE ROOT COMPRESSION. RIGHT L4-L5 FACET CYST. L5-S1 RIGHT-SIDED DISK HERNIATION. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: L4-5 DISKECTOMY, DECOMPRESSION, AND BILATERAL FORAMINOTOMY. L4-L5 ARTHRODESIS AND POSTERIOR LUMBAR INTERBODY FUSION. L4-L5 PLACEMENT OF POLYETHERETHERKETONE (PEEK) IMPLANTS WITH RHBMP-2/ACS AND AUTOLOGOUS BONE MEASURING 14 X 26 MM X 2. L4-L5 INTERSEGMENTAL STABILIZATION. RIGHT L5-S1 DECOMPRESSION AND FORAMINOTOMY. INTRATHECAL INJECTION OF MORPHINE FOR PAIN CONTROL. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270534 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 53 YR Required Intervention