BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2935988 · Received January 30, 2013

    Report

    Report Number
    1030489-2013-00310
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    February 22, 2008
    Report Date
    June 12, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 USED 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO.

    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 UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "SERIOUS PAIN, [PATIENT] FREQUENTLY VISITS DOCTOR AND [PATIENT] CONSTANTLY WORRIED ABOUT NEEDING ANOTHER SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2008: PATIENT UNDERWENT REMOVAL OF HARDWARE, EXPLORATION OF FUSION, POSTERIOR SPINAL FUSION L4-S1. PRE-OP DIAGNOSES: ADJACENT LEVEL DEGENERATION, LOW BACK PAIN, LUMBAR RADICULOPATHY, LUMBAR SPONDYLOSIS. PER OP-NOTES: TWO LEAD EBI INTERNAL BONE STIMULATOR WITH ONE LEAD EACH IN THE LATERAL GUTTERS. THESE WERE PLACED ACTUALLY PRIOR TO FULL INSERTION OF THE SCREWS ALONG WITH RHBMP-2 AND ALLOGRAFT BONE GRAFT TO THIS. ON (B)(6) 2008: PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: STATUS POST LOWER LUMBAR FUSION AND ASSOCIATED LUMBOSACRAL STIMULATION DEVICE. NO EVIDENCE OF ACUTE COMPRESSION FRACTURE OR SUBLUXATION. PARTIAL FUSION OF THE L5-S1 INTERVERTEBRAL DISC SPACE. ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP OF HIS LUMBAR SPINE. CT SCAN SHOWED SOLID FUSION L4-S1. ON (B)(6) 2008, (B)(6) 2009: PATIENT PRESENTED WITH LOW BACK PAIN IN AN OFFICE VISIT. ON (B)(6) 2009: PATIENT PRESENTED WITH PAINFUL INTERNAL DEVICE. ON (B)(6) 2014: PATIENT UNDERWENT X-RAY AND CT OF LUMBAR SPINE 2/3 VIEWS. IMPRESSION: INTERVAL REVISION OF L4-S1 PLIF WITH DORSAL DECOMPRESSION OF THE CANAL. HARDWARE IS INTACT. BONE STIMULATOR DEVICE IN SITE DORSAL TO THE LUMBOSACRAL JUNCTION. PROGRESSION OF L3-4 SPONDYLOSIS WITH MILD/ MODERATE THECAL STENOSIS ON WEIGHT BEARING IMAGES. APPARENT MASS EFFECT ON BILATERAL DESCENDING L4 NERVE ROOTS IN THE L3-4 SUBARTICULAR RECESSES ON WEIGHT BEARING IMAGES. NO PATHOLOGIC MOTION WITH FLEXION-EXTENSION.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT UNDERWENT A SPINE FUSION SURGERY IN THE LUMBAR SACRAL REGION OF HIS SPINE IN ORDER TO ATTEMPT TO FUSE VERTEBRAE L4 TO S1. DURING THE SURGERY'S POST-OPERATIVE PERIOD THE PATIENT WAS MARKED WITH INCREASING LOWER BACK PAIN THAT RADIATED TO HIS LOWER EXTREMITIES. THE PATIENT RELIED ON A SURGICALLY IMPLANTED SPINAL CORD STIMULATOR TO MITIGATE HIS PAIN SYMPTOMS WITH MIXED RESULTS. IT WAS REPORTED THAT THE PATIENT HE CONTINUES TO EXPERIENCE NERVE INJURY AND SEVERE LOW BACK PAIN THAT RADIATES INTO HIS LOWER EXTREMITIES, AND HAS OTHERWISE SUFFERED SERIOUS INJURIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT WAS ADMITTED AND PRESENTED WITH FOLLOWING PRE OPERATIVE DIAGNOSIS: ADJACENT LEVEL DEGENERATION, L4-5 WITH LUMBAR SPINAL STENOSIS. LUMBAR RADICULOPATHY. LOW BACK PAIN, SPONDYLOSIS. L5-S1 PSEUDOARTHROSIS. HE UNDERWENT THE FOLLOWING PROCEDURES: REVISION DECOMPRESSION, L5; PARTIAL DECOMPRESSION, L4 WITH LAMINECTOMY AND PARTIAL FACETECTOMY AND BILATERAL FORAMINOTOMIES, L4-5. REMOVAL OF HARDWARE OF L5-S1. EXPLORATION OF FUSION. POSTERIOR ARTHRODESIS, L4 TO S1 WITH INSTRUMENTATION, RHBMP-2 LOCAL AND ALLOGRAFT BONE GRAFT. INSERTION OF INTERNAL BONE STIMULATOR. AS PER THE OPERATIVE NOTES, ¿WE PLACED A TWO LEAD EBI INTERNAL BONE STIMULATOR WITH ONE LEAD EACH IN THE LATERAL GUTTERS. THESE WERE PLACED ACTUALLY PRIOR TO FULL INSERTION OF THE SCREWS ALONG WITH RHBMP-2 AND ALLOGRAFT BONE INTO THE LATERAL GUTTERS AND THEN WE SUBSEQUENTLY ADDED LOCAL BONE GRAFT TO THIS. WE ALSO PACKED BONE GRAFT INTO THE DECORTICATED FACET JOINTS AT L4-S AND LS-S1 BILATERALLY.¿ THE PATIENT WAS DISCHARGED ON (B)(6) 2008. NO INTRA OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40477 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110614AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention