BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2862146 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02678
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2004: LUMBAR SPINE SERIES WITH OBLIQUES SPONDYLOLYSIS AT L5-S1 ON THE RIGHT SIDE IS HIGHLY SUSPECTED. NO OTHER ABNORMALITY IS SEEN. ON (B)(6) 2005 DIAGNOSIS: LUMBAR DDD WHILE LIFTING PATIENT NOTED BACK AND BILATERAL RADICULOPATHY IN (B)(6) OF 2004. PATIENT HAS PROGRESSIVELY WORSENED. PAIN STARTS AT WAIST AND RADIATED TO HIP AND LOWER EXTREMITIES. LOWER BACK PAIN IS WORSE THAN LEG PAIN AND RIGHT LEG IS WORSE THAN LEFT LEG. NUMBNESS AND PARATHESIS NOTED IN FEET. PROCEDURE: LUMBAR DISCOGRAM AND DISCOGRAM DONE (B)(6) 2005 DIAGNOSIS:ADMITTED TO HOSPITAL LOWER BACK PAIN WITH RADICULOPATHY. L5-S 1 DISCO GENIC PAIN. ON (B)(6) 2005 LS-S I MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION LUMBAR SPINE MAGNETIC RESONANCE IMAGING REVEALED MULTI-LEVEL MILD TO MODERATE DEGENERATIVE DISC DISEASE AND SPONDYLOSIS. LOWER BACK PAIN WITH RADICULOPATHY, L5-S1 DISCO GENIC PAIN (B)(6) 2005 PHYSICAL THERAPY APPT BACK PAIN, HERNIATED DISC (B)(6) 2005 PHYSICAL THERAPY APPT BACK PAIN, HERNIATED DISC B)(6) 2005 AP AND LATERAL VIEWS OF THE LUMBOSACRAL SPINE POSTERIOR FIXATIONWITH PEDICLE SCREWS AND RODS IS SEEN BETWEEN L5 AND S1. THERE HAS BEEN NO CHANGE IN THE POSITION OF THE HARDWARE OR VERTEBRAL BODIES. CONCLUSION: SLIGHT MIDLINE DISC PROTRUSION AT L5-S1, OTHERWISE NORMAL MRI OF THE LUMBAR SPINE. ON (B)(6) 2006 REASON FOR ORDER: ADM SIP FUSION L4 SL C/O SEVERE MUSCLE SPASM AT THORACOLUMBAR REGION SENSORY INTACT, DTR+2 ALL OTHER EXAM DEFERRED SECONDARY TO PAIN. AP AND LATERAL VIEWS OF THE THORACIC SPINE REVEAL THE VERTEBRAL BODIES TO BE OF NORMAL HEIGHT WITH ADEQUATE. MAINTENANCE OF THE INTERVERTEBRAL DISC SPACES. THERE IS NO EVIDENCE OF TRAUMATIC, NEOPLASTIC OR SIGNIFICANT ARTHRITIC CHANGE. THE SMALL DENSITY NOTED BETWEEN TID AND TIL VERTEBRAL BODIES AS SEEN IN THE LATERAL VIEW COULD POSSIBLY BE DUE TO OLD INJURY OR LIGAMENTOUS CALCIFICATION. IMPRESSION: NORMAL THORACIC SPINE. ON (B)(6) 2008: NM BONE AND/OR JOINT IMAGING, LIMITED AREA LOW BACK PAIN. PRIOR LUMBAR FUSION WITH HARDWARE. NO ABNORMALITIES FOUND. ON (B)(6) 2009 CT THORACIC SPINE WITH NO CONTRAST PATIENT HAS PAIN AND HISTORY OF FALL NO FRACTURE OR LISTHESIS NORMAL ALIGNMENT. ON (B)(6) 2009: PHYSICIAN VISIT POST FUSION, PATIENT STILL HAS LOW BACK PAIN SPECT AND MRI IMAGING ARE ALL NORMAL DISCUSSED SPINAL INJECTIONS AND MEDICINE THERAPY WILL FOLLOW UP WITH A PLAN ON (B)(6) 2008: PHYSICIAN VISIT PATIENT STILL HAS PAIN. HAS UNDERGONE MULTIPLE SPINAL INJECTIONS, MEDICINE, AND PHYSICAL THERAPY BUT HAS NOT SEEN GOTTEN ANY RELIEF FROM THE PAIN. ON (B)(6) 2010: PATIENT HAD POSTERIOR LATERAL FUSION WITH PLATE-SCREW FIXATION DEVICES FROM L5-31. NO EVIDENCE OF HARDWARE FAILURE BY PLAIN RADIOGRAPHS. THERE IS DISC SPACE NARROWING AT L5-S1, AND SEVERAL METAL CLIPS ARE NOTED OVER THE L5-S1 DISC SPACE. THERE IS MINOR OSTEOPHYTOSIS AT L2-L3 WITH SLIGHT NARROWING OF THE DISC SPACE. S1 JOINTS ARE UNREMARKABLE. ON (B)(6) 2010 FOLLOW UP VISIT FOR PAIN MANAGEMENT CONTINUE WITH SPINAL INJECTIONS AND PAIN MEDICINE (B)(6) 2009 CT LUMBAR SPINE WITH CONTRAST PATIENT STILL HAS LOW BACK PAIN ALIGNMENT OF THE LUMBAR VERTEBRAL BODIES IS NORMAL. NO FRACTURE OR LISTHESIS. STABLE MILD SPONDYLOTIC CHANGES. LS-SL POSTOPERATIVE CHANGE WITH POSTERIOR POSITION OF THE INTERBODY GRAFT ASSOCIATED BONY RIDGE RESULTING IN MINIMAL RIGHT LATERAL RECESS MODERATE RIGHT NEURAL FORAMINAL STENOSIS. NO SIGNIFICANT BONY BRIDGING ACROSS THE LS-SL INTERSPACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA ML14005AAG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other