BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191861 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02565
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    December 5, 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    ADD'L INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION AT L4-5, L5-S1 USING RHBMP-2 MIXED WITH AUTOGRAFT AND MASTERGRAFT AND PLACED ON MULTIPLE LEVELS. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH INJURIES, INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT: LAMINECTOMY L5, LAMINOTOMY L4; POSTERIOR LUMBAR INTERBODY FUSION AT L4-5 (14X22 CAGES), L5-S1 (12X26 CAGES); LOCAL BONE GRAFT WITH BMP, BONE GRAFT FOR FUSION; PEDICLE SCREW SEGMENTAL INSTRUMENTATION AT L4/5-S1 FOR REDUCTION SPONDYLOLISTHESIS AT L5-S1. PREOPERATIVE DIAGNOSIS: SPONDYLOLISTHESIS L5-S1, DEGENERATIVE LUMBAR DISC DISEASE, FACET DISC DISEASE AT L4-5 AND L5-S1, AND LEFT LEG PAIN. PER-OP NOTES: ¿AT L4-5, 14X22 CAGES WERE PLACED AFTER BMP AND BONE HAD BEEN INTRODUCED ANTERIORLY ALONG WITH BONE GRAFT. THE CAGES WERE COUNTERSUNK UNDER FLUOROSCOPIC GUIDANCE AND LOOKED GOOD. AT L5-S1, THE INTERBODY ALSO WAS HIGHLY DEGENERATED DISC MATERIAL. THE ROOTS WERE EASILY DECORTICATED AND 12X26 CAGE WAS PLACED. THESE HAD BEEN IMPACTED WITH BONE AND BMP, AND BONE AND BMP WITH BONE GRAFT HAD BEEN PLACED ANTERIORLY TO THIS AND INTO THE DISC SPACE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290142 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention