BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3963889 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03334
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    December 7, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2008, THE PATIENT WAS ADMITTED TO UNDERWENT PROCEDURE. (B)(6) 2008, THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF 1) SPINAL STENOSIS L4-5. 2) CENTRAL DISK HERNIATION L4-5. 3) RIGHT L5-S1 HERNIATED DISK 4) BILATERAL L4 SPONDYLOLYSIS WITHOUT SPONDYLOLISTHESIS. THE PATIENT UNDERWENT FOLLOWING PROCEDURES : 1) PARTIAL LAMINECTOMY L3, L5. 2)BILATERAL LAMINECTOMY L4. 3) LAMINECTOMY AND DISCECTOMY RIGHT L5-S1. 4) POSTERIOR INTERBODY FUSION, L4-5. 5) POSTEROLATERAL FUSION L4-5. 6) INSERTION OF TRICORTICAL ALLOGRAFT PROSTHESES ,LEFT L4-5. 7) INSERTION OF ALLOGRAFT CANCELLOUS BONE CHIPS AND BMP. 8) INSERTION OF AUTOGRAFT BONE AND SPINAL INSTRUMENTATION AT L4-5. PER OP NOTES, THE SURGEON CUT A TRICORTICAL ALLOGRAFT PROSTHESIS . THEY PREPARED CRUSHED CANCELLOUS ALLOGRAFT BONE CHIPS WHICH WAS MIXED WITH BMP. THE ALLOGRAFT CHIPS AND BMP WAS PLACED ANTEROLATERALLY. THE ALLOGRAFT PROSTHESIS WAS PLACED AND THEN POSTERIOR TO THIS ALLOGRAFT BONE AND BMP WAS PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE FUSION SURGERY ON THE LUMBAR REGION OF HIS SPINE FROM L4 TO L5 IN WHICH RHBMP-2/ACS WAS USED. REPORTEDLY, THE PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE RIGHT-SIDED PAIN AND WEAKNESS IN HIS LOWER BACK RADIATING INTO HIS RIGHT LOWER EXTREMITY. A CT SCAN TAKEN (B)(6) 2008 REPORTEDLY INDICATED DISC HERNIATION AND STENOSIS COMPRESSING HIS NERVE ROOTS AT THE LEVEL OF HIS IMPLANT. IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A REVISION SURGERY ON THE LUMBAR REGION OF HIS SPINE FROM L5 TO S1 IN WHICH RHBMP-2/ACS WAS USED. AN MRI TAKEN (B)(6) 2012 REVEALS RECURRENT SPINAL STENOSIS AND DISC BULGES COMPRESSING THE NERVE ROOTS AT THE LEVELS OF IMPLANT. REPORTEDLY, PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING LOW BACK PAIN THAT RADIATES INTO HIS LOWER EXTREMITIES AND IMPEDES HIS ABILITY TO AMBULATE, SIT AND STAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441297 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110703AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention