BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191884 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02567
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    December 12, 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). (B)(6). 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTEROLATERAL APPROACH FUSION AT L5-S1 USING RHBMP-2/ACS ¿WITH MASTOGRAPH¿ AND AN ALEUTIAN VERTEBRAL SPACER. 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 HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 THE PATIENT UNDERWENT: L5-S1 LAMINECTOMY L5-S1 DISCECTOMY, L5-S1 ARTHRODESIS WITH INSERTION OF INTERBODY FUSION DEVICE AND INTERBODY FUSION AND L5-S1 POSTEROLATERAL FUSION WITH INSTRUMENTATION. PREOPERATIVE DIAGNOSIS: GRADE 1 SPONDYLOLISTHESIS AT L5-S1 AND INTRACTABLE LOWER BACK PAIN. IMPLANTS UTILIZED: K-2 MESA POSTEROLATERAL INSTRUMENTATION SET, K2 ALEUTIAN INTERBODY SPACER, RHBMP-2/ACS, BONE GRAFT AUTOLOGOUS LOCAL BONE AND AUTOLOGOUS GROWTH FACTOR. PER-OP NOTES: ¿L5 WAS EXTREMELY LOW LYING ON THE RIGHT SIDE, AND I WAS UNSURE AS TO WHETHER I COULD GET IN WITH AN INTERBODY GRAFT ON THAT SIDE, BUT EVENTUALLY WE DID. WITH APPROPRIATE NERVE ROOT RETRACTION, THE L5-S1 INTERSPACE WAS EXPOSED.¿ ON (B)(6) 2008 THE PATIENT UNDERWENT EXPLANT OF LUMBAR INSTRUMENTATION. PREOPERATIVE DIAGNOSIS: INTRACTABLE LOWER BACK PAIN SECONDARY TO INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291612 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 00025 YR Required Intervention