BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3170733 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02289
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    August 15, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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.

    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 ON (B)(6) 2004, PATIENT UNDERWENT FOLLOWING PROCEDURE: EXPLORATION OF POSTEROLATERAL FUSION T12-L1, L1-2 AND L2-3; REMOVAL OF POSTERIOR SPINAL INSTRUMENTATION L2 AND L3; BILATERAL REVISION LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY S1; BILATERAL REVISION LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY L5; BILATERAL LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY L4; POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION UTILIZING PEDICLE SCREWS/ROD CONSTRUCT WITH INTRASACRAL FIXATION L2 TO THE SACRUM; BILATERAL POSTEROLATERAL INTRATRANSVERSE FUSION AT L5-S1 UTILIZING AUTOGENOUS BONE AUGMENTED WITH RHBMP-2 AND DBX DEMINERALIZED BONE MATRIX ; BILATERAL POSTEROLATERAL INTRA TRANSVERSE FUSION(REPAIR OF PSEUDOARTHROSIS) AT L4-5 UTILIZING AUTOGENOUS BONE AUGMENTED WITH RH BMP-2 AND DBX DEMINERALIZED BONE MATRIX; HARVESTING LOCAL BONE GRAFT FROM THE SPINE; INSERTION OF INTRATHECAL CATHETER UNDER DIRECT VISION UTILIZING A DIRECT INTERLAMINAR APPROACH AT THE L1-2 LEVEL PRE-OP AND POST-OP DIAGNOSIS: STATUS POST ARTHRODESIS SEGMENTAL INSTRUMENTATION T3 TO L5; PROBABLE VERTEBRAL OSTEOMYELITIS L4 AND L5; FAILURE OF POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION WITH LUMBAR SPINE INSTABILITY; L4-5 FORAMINAL STENOSIS SECONDARY TO INSTABILITY AND SEGMENTAL COLLAPSE AS PER OP NOTES: ".. POSTEROLATERAL ARTHRODESIS AND REPAIR OF POSTEROLATERAL PSEUDOARTHROSIS WAS THEN EFFECTED UTILIZING A COMBINATION OF LOCALLY HARVESTED AUTOGENOUS BONE, WHICH HAD BEEN PREPARED IN THE BONE MILL, A COLLAGEN SPONGE DOSED WITH RHBMP-2 AND DBX DEMINERALIZED BONE MATRIX PUTTY. THE COMBINATION WAS CAREFULLY PACKED INTO THE DECORTICATED POSTEROLATERAL REGION AT L4-5 AND L5-S1.. NO COMPLICATIONS WERE REPORTED.."

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-S1 POSTEROLATERAL FUSION WITH IMPLANT OF RHBMP-2 MIXED WITH AUTOGENOUS BONE AND DBM. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271909 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention