BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3161779 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02146
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    August 8, 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

    (B)(4).

    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 L3-S1 POSTERIOR FUSION WITH IMPLANT OF RHBMP-2, AUTOGRAFT, AND PEDICLE SCREW INSTRUMENTATION 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

    ON OR AROUND 2004, THE PATIENT WAS DIAGNOSED WITH CHRONIC PAIN. ON (B)(6) 2004, THE PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INTERBODY FUSION USING RHBMP-2/ACS. POST RH-BMP2/ACS SURGERY, THE PATIENT HAS BEEN INJURED AND SUFFERS INJURIES TO HER BODY AND MIND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2004: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: PREVIOUSLY OPERATED LUMBAR SPINE. LUMBAR KELOID. SYMPTOMATIC SPINAL IMPLANTS. PSEUDOARTHROSIS. MORBID OBESITY. CHRONIC NICOTINE ABUSE. DIABETES. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LUMBAR KELOID EXCISION. REMOVAL OF SYNTHES CLICK ¿X PEDICLE SCREW INSTRUMENTATION. EXPLORATION OF FUSION, RESECTION OF PSEUDOARTHROSIS. REMOVAL OF BONE GROWTH STIMULATOR BATTERY PACK AND ELECTRODES. L4-S1 INTERNAL FIXATION WITH INSTRUMENTATION. L3-S1 INTERTRANSVERSE FUSION USING ILIAC CREST BONE GRAFT. PREPARATION AND APPLICATION OF BMP. AS PER OP-NOTES: CORTICANCELLOUS GRAFT MATERIAL WAS PLACED IN INTERTRANSVERSE AREA L3 TO SACRUM BILATERALLY. COLLAGEN SPONGES WERE DIVIDED. BMP WAS PREPARED AND PLACED OVER COLLAGEN SPONGES AND ALLOWED TO CURE. COLLAGEN SPONGES WERE PLACED IN INTERTRANSVERSE AREA L3 TO SACRUM AND ADDITIONAL BONE GRAFT WAS PLACED POSTERIOR TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262803 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 46 YR Required Intervention