BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5063456 · Received September 9, 2015

    Report

    Report Number
    1030489-2015-02265
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    August 11, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH BACK PAIN AND L LE NUMBNESS. IT WAS OBSERVED THAT SHE HAD SYMPTOMS SUGGESTIVE OF AN L4-5, LE R AT AND EHL WEAKNESS, NUMBNESS IN THE 1ST WEB SPACE AND MEDIAL ANKLE AND L L5-S1 WEAKNESS WITH NUMBNESS IN THE L LATERAL FOOT/CALF. ON (B)(6) 2008 THE PATIENT UNDERWENT MRI FOR LUMBAR SPINE IN WHICH IT WAS OBSERVED THAT CONGENITAL STENOSIS, PREVIOUS LEST LAMINOTOMIES L4-5 AND L5-S1, MILD FACET ARTHROPATHY AND FORAMINAL STENOSIS. SHE ALSO UNDERWENT X-RAYS IN WHICH MILD DEGENERATIVE CHANGES WERE OBSERVED. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT WITH BACK PAIN AND L LE NUMBNESS. DIAGNOSIS: LUMBAR RADICULOPATHY; LUMBAR POSTLAMINECTOMY SYNDROME; LUMBAR SPINAL STENOSIS. ON (B)(6) 2008 THE PATIENT RECEIVED THE LEG BRACES. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT WITH BACK PAIN AND L LE NUMBNESS. SHE HAD EPIDURALS BEFORE AND WAS S/P LEFT LUMBAR LAMINOTOMY ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT WITH BACK PAIN AND L LE NUMBNESS. THE PATIENT ALSO UNDERWENT A PROCEDURE. PREOPERATIVE DIAGNOSIS: LEFT HIP PAIN, RIGHT TROCHANTERIC BURSITIS; PROCEDURE: LEFT TROCHANTERIC STEROID INJECTION. ON (B)(6) 2009: THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT WITH BACK PAIN, L LE NUMBNESS AND LEFT HIP PAIN. DIAGNOSIS : LUMBAR RADICULOPATHY; LUMBAR POSTLAMINECTOMY SYNDROME; LUMBAR SPINAL STENOSIS; BURSITIS TROCHANTERIC, LEFT; JOINT PAIN, HIP. SHE ALSO UNDERWENT A PROCEDURE. PREOPERATIVE DIAGNOSIS: LEFT HIP PAIN, RIGHT TROCHANTERIC BURSITIS; PROCEDURE: LEFT TROCHANTERIC STEROID INJECTION. ON (B)(6) 2009 THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT WITH BACK PAIN, L LE NUMBNESS, LEFT HIP PAIN AND LEFT LEG PAIN. DIAGNOSIS: LUMBAGO, LUMBAR DEGENERATIVE DISC DISEASE, LUMBAR POSTLAMINECTOMY SYNDROME. SHE ALSO UNDERWENT LEFT TROCHANTERIC STEROID INJECTION. ON (B)(6) 2009 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH BACK PAIN, L LE NUMBNESS, LEFT HIP PAIN AND LEFT LEG PAIN. DIAGNOSIS : LUMBAR RADICULOPATHY; LUMBAR POSTLAMINECTOMY SYNDROME; LUMBAR SPINAL STENOSIS; BURSITIS TROCHANTERIC, LEFT; JOINT PAIN, HIP. ON (B)(6) 2009 THE PATIENT UNDERWENT A SURGERY. DIAGNOSIS : LUMBAR RADICULOPATHY; LUMBAR POSTLAMINECTOMY SYNDROME; LUMBAR SPINAL STENOSIS; BURSITIS TROCHANTERIC, LEFT; JOINT PAIN, HIP; LUMBAGO; LUMBAR DEGENERATIVE DISC DISEASE; BURSITIS TROCHANTERIC, LEFT; JOINT PAIN, HIP. SURGERY PROCEDURE: LT. L5-S1 TLIF, L5-S1 LAMINOTOMY, REDO LT. L4-5 LAMINOTOMY POSSIBLE LT. L3-4 LAMINOTOMY. ON (B)(6) 2009 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR FOLLOW UP ON HER PROGRESS. ON (B)(6) 2009: PATIENT GOT DISCHARGED WITH DISCHARGE DIAGNOSIS OF: STATUS POST LEFT L4-5, L5-S1, TRANSVERSE LUMBAR INTERBODY FUSION, POSTEROLATERAL ARTHRODESIS, PLACEMENT OF INTER BODY CAGES, SEGMENTAL INSTRUMENTATION, L4-5, L5-S1, REDO LEFT L4-5 LAMINOTOMY, LEFT L5-S1 LAMINOTOMY, LOCAL BONE GRAFTING. LUMBAR RADICULITIS. LUMBAR SPONDYLOSIS. POSTLAMINECTOMY SYNDROME. ON (B)(6) 2009 THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT FOR WITH BACK PAIN, L LE NUMBNESS, LEFT HIP PAIN AND LEFT LEG PAIN. PAIN HAD WORSENED. MEDICATIONS CHANGED. ON (B)(6) 2009: THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF LUMBAR RADICULITIS. LUMBAR SPONDYLOSIS. POSTLAMINECTOMY SYNDROME. FOR WHICH PATIENT UNDERWENT FOLLOWING PROCEDURES: LEFT L4-5, L5-S1, TRANSVERSE LUMBAR INTERBODY FUSION. POSTERIOR LUMBAR ARTHRODESIS, L4-5, L5-S1. SEGMENTAL INSTRUMENTATION, L4-5, L5-S1. PLACEMENT OF CAGES L4-5, L5-S1. LEFT REDO L4-5 LAMINECTOMY. LEFT L5-S1 LAMINECTOMY. LOCAL BONE GRAFTING. PER OP NOTES, LEFT TRANSVERSE LUMBAR INTERBODY FUSION WAS PERFORMED TO THE LEFT L4-5 AND L5-S1. THE SCREWS WERE PLACED WITHOUT ANY DIFFICULTIES. THERE WAS NO SPINAL CORD MONITORING CHANGES WITH INSTRUMENTATION, NONE OF THE SCREWS MET THE CRITERIA FOR NERVE ROOT IRRITATION. THE POSTEROLATERAL FUSION WAS PERFORMED TO THE RIGHT AT L4-5, L5-S1. IN ADDITION, THE MOST ANTERIOR ASPECT OF THE INTERSPACE WAS ALSO PACKED WITH BMP, BONE GRAFT AND LOCAL BONE GRAFT PRIOR TO INSERTION OF THE CAGES. THE PROPER POSITIONING OF THE CAGES WAS CONFIRMED ON AP AND LATERAL VIEWS. USING A COMBINATION OF LOCAL AUTOGRAFT, BMP AND BONE GRAFT WAS LAID DOWN OVER THE POSTEROLATERAL GUTTERS. HEMOSTASIS WAS OBTAINED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2009 THE PATIENT UNDERWENT X-RAYS FOR LUMBAR SPINE. ON (B)(6) 2009 THE PATIENT UNDERWENT X-RAYS FOR LUMBAR SPINE. NO COMPLICATION WAS REPORTED. ON (B)(6) 2009 THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT FOR WITH BACK PAIN, L LE NUMBNESS, LEFT HIP PAIN AND LEFT LEG PAIN. NO COMPLICATION WAS REPORTED. ON (B)(6) 2009, (B)(6) 2010 THE PATIENT WAS PRESENTED WITH PAIN IN HER GROIN, LOW BACK AND LATERAL THIGH. MEDICATIONS DECREASED. ON (B)(6) 2010 THE PATIENT WAS PRESENTED FOR FOLLOW-UP OFFICE VISIT FOR WITH BACK PAIN, L LE NUMBNESS, LEFT HIP PAIN AND LEFT LEG PAIN. CONTINUES TO HAVE PAIN IN HER L HIP AND LOW BACK. ON (B)(6) 2010 THE PATIENT WAS PRESENTED WITH WORSENED PAIN LOCALIZED TO THE LOW BACK AND L THIGH AND NUMBNESS IN HER LEFT FOOT. ON (B)(6) 2010 THE PATIENT WAS PRESENTED WITH LOW BACK PAIN AND LLE NUMBNESS. MEDICATIONS PROLONGED. ON (B)(6) 2010 THE PATIENT UNDERWENT CT LUMBAR MYELOGRAM. IMPRESSIONS: PATIENT WAS S/P DISCECTOMIES WITH POSTERIOR LUMBAR FUSION AT THE L4-5 AND L5-S1 LEVELS. DISC SPACERS, PEDICLE SCREWS AND POSTERIOR RODS APPEARED IN GOOD POSITION AND ALIGNMENT. SPINAL CANAL WAS WIDELY PATENT THROUGHOUT THE POST-OPERATIVE REGION, AND NO SIGNIFICANT COMPRESSION OF THE THECAL SAC WAS IDENTIFIED. THE LEFT NEURAL FORAMEN AT THE L4-5 LEVEL WAS NOT OPTIMALLY VISUALIZED SECONDARY TO METALLIC STREAK ARTIFACT. SMALL DIFFUSE DISC BULGES WERE PRESENT AT THE L2-3 AND L3-4 LEVELS WITH MILD VENTRAL INDENTATION OF THE THECAL SAC AT EACH LEVEL, HOWEVER, THIS DOES NOT PRODUCE SIGNIFICANT SPINAL STENOSIS OR FOCAL ASYMMETRIC NEURAL FORAMINAL NARROWING. CONUS APPEARED UNREMARKABLE. ON (B)(6) 2010 THE PATIENT WAS PRESENTED WITH COMPLAINTS OF L THIGH PAIN, L FOOT PAIN AND LOW BACK PAIN. IT WAS OBSERVED THAT THERE WAS A CONGRUENT NERVE ROOT WITH MILD FORAMINAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597272 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110807AAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other