BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3201285 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02880
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    March 14, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION SURGERY AT LS-S1. THE SURGERY CONSISTED OF POSTERIOR INTERBODY FUSION AND LATERAL FUSION USING ILIAC CREST BONE GRAFT AS WELL AS SOME LOCAL AUTOGRAFT COMBINED WITH RHBMP-2/ACS. THE SURGERY WAS REPORTEDLY DONE AT MULTIPLE LEVELS. POST-OP, THE PATIENT HAS SUSTAINED EXTREME PAIN, SUFFERING, AND ANGUISH FROM HIS LUMBAR SPINE FUSION SURGERY. REPORTEDLY, BMP CAUSED ABNORMAL ECTOPIC BONE GROWTH, WHICH IN TURN CAUSED HIS ONGOING, CHRONIC PAIN AND OTHER COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2008, THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF SPINAL STENOSIS, FORAMINAL STENOSIS BILATERALLY L5-S1, SPONDYLOLISTHESIS L5-S1, DEGENERATIVE DISC AND JOINT DISEASE AT L5-S1, NUCLEUS PULPOSUS L5-S1, GAIT DISTURBANCE, SCOLIOSIS, SPINAL CURVE LUMBAR SPINE, RADICULOPATHY L5, S1. THE PATIENT UNDERWENT FOLLOWING PROCEDURE: LEFT SIDED TRANSPEDICULAR POSTERIOR NEURAL DEPRESSION S1. RIGHT SIDED TRANSFORAMINAL POSTERIOR INTERBODY FUSION AT L5-S1. CAGE INSTRUMENTATION, TITANIUM L5-S1. PEDICLE INSTRUMENTATION BILATERAL L5. BILATERAL S1 TRANSVERSE PROCESS POSTERIOR LATERAL FUSION L5-S1. PER OP NOTES, "... A 15 X 30 MM TITANIUM CAGE FILLED WITH CANCELLOUS AUTOLOGOUS BONE AND BMP WAS PLACED IN THE INNER DISK SPACE AFTER IT HAD BEEN IRRIGATED AFTER THEN PACKED WITH CANCELLOUS AUTOLOGOUS BONE AND BMP .." IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED INJURIES DUE TO RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303181 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110704AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other