BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4171450 · Received October 14, 2014

    Report

    Report Number
    1030489-2014-04029
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT LUMBAR FUSION PROCEDURE IN WHICH RHBMP-2/ACS, GRAFTON MATRIX STRIPS, FLOSEAL HEMOSTATIC MATRIX, GLOBUS SCREWS, LOCKING CAGE AND CURVED RODS WERE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT PRESENTED WITH LOW BACK PAIN, HIP AND LEG PAIN, AND FOOT NUMBNESS. A CT OF THE LUMBAR SPINE INDICATED ¿ANTERIOR AND POSTERIOR DECOMPRESSION AND INSTRUMENTATION HAVE BEEN PERFORMED AT THE L4-5 AND L5-S1 LEVELS. AT L4-5, SOLID INTERBODY FUSION IS SEEN EXTENDING PERIPHERAL TO THE INTERBODY DEVICE TO THE RIGHT OF MIDLINE IN THE INTERSPACE. FUSION BONE MATERIAL WITHIN THE DEVICE HAS PSEUDOARTHROSIS WITHIN IT. THE FUSION IS RELATIVELY MINIMAL TO THE FAR RIGHT OF MIDLINE BRIDGING FROM UPPER L5 TO LOWER S1 END PLATE AND EXTENDING INTO THE FORAMEN AND FAR LATERAL POSITIONS. AT L5-S1, THERE IS FAILED FUSION ACROSS THE INTERSPACE WITH NO BRIDGING BONE VISIBLE EITHER WITHIN OR PERIPHERAL TO THE INTERBODY DEVICE. BILATERAL L4, L5, AND S1 PEDICLE SCREWS AND POSTERIOR ROD INSTRUMENTATION ARE IN PLACE, IN SATISFACTORY POSITION AT ALL THREE LEVELS. THERE IS NO RESIDUAL CENTRAL CANAL STENOSIS. MILD RESIDUAL BILATERAL FORAMINAL STENOSIS IS OBSERVED, SOMEWHAT GREATER RIGHT THAN LEFT AT BOTH LEVELS. LEFT SIDED POSTEROLATERAL FUSION BONE IS OBSERVED, WITH A FAIRLY LOW DENSITY APPEARANCE THOUGH THERE MAY BE SOME BRIDGING OF THE POSTERIOR ELEMENTS AT BOTH LEVELS. THERE IS A GREATER SUGGESTION OF BRIDGING BONE AT L4-5 AND AT L5-S1 WHERE THERE IS PERSISTENT LUCENCY THROUGH THE POSTERIOR ELEMENT FUSION BONE.¿ ON (B)(6) 2012 THE PATIENT PRESENTED WITH LUMBAR RADICULOPATHY STATUS POST FUSION. A CT OF THE LUMBAR SPINE INDICATED ¿INTERVAL REMOVAL OF L4 PEDICLE SCREWS SINCE (B)(6) 2012. THE PATIENT IS POST OP L3-4 LAMINECTOMY WITH INTERVAL DECOMPRESSION OF A CRITICAL CENTRAL CANAL STENOSIS AT THIS LEVEL. MODERATE CENTRAL CANAL STENOSIS HAS DEVELOPED AT L2-3. INTERBODY IMPLANTS REMAIN AT L4-5 AND L5-S1 WITH PEDICLE SCREW SECURING POSTERIOR FUSION OF L5-S1.¿ IT WAS REPORTED THAT THE PATIENT DEVELOPED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650561 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110911AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other