BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3170714 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02288
    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

    (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

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR ANTERIOR FUSION FROM T11-L2 WHERE RHBMP-2 WAS IMPLANTED AT MULTIPLE LEVELS. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2003, PATIENT UNDERWENT FOLLOWING PROCEDURE: BILATERAL REVISION LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY T8; BILATERAL REVISION LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY T9; BILATERAL REVISION LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY T10; BILATERAL REVISION LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY T11; BILATERAL PARTIAL LAMINECTOMY T7; BILATERAL PARTIAL LAMINECTOMY T12; MULTILEVEL OSTEOTOMIES OF THE THORACIC SPINE FOR CORRECTION OF RIGID THORACIC KYPHOSIS: T4-5, T5-6, T6-7, T7-8, T8-9, T9-10, T10-11, T11-12; BILATERAL POSTEROLATERAL ARTHRODESIS AND FUSION FOR CORRECTION OF JUNCTIONAL THORACOLUMBAR KYPHOSIS AND INSTABILITY: T4-5, T5-6, T6-7, T7-8, T8-9, T9-10, T10-11, T11-12, T12-L1, L1-2; POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION UTILIZING A PEDICLE SCREW/ROD CONSTRUCT: T2 TO L2; HARVESTING OF AUTOGENOUS LOCAL BONE GRAFT FROM THE THORACIC AND LUMBAR SPINE; REPAIR OF REGION OF DURAL ECTASIA PRE-OP AND POST-OP DIAGNOSIS: POST LAMINECTOMY SYNDROME; ACQUIRED THORACOLUMBAR INSTABILITY WITH KYPHOTIC DEFORMITY; MULTILEVEL THORACIC SPONDYLOSIS WITH MYELOPATHY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2003, PATIENT UNDERWENT FOLLOWING PROCEDURE: LEFT SIDED T8 THORACOTOMY WITH EXCISION OF THE EIGHTH RIB. MULTI-LEVEL ANTERIOR OSTEOTOMY/PATIAL VERTEBRECTOMY INCLUDING DECOMPRESSION AND COMPLETE DISCECTOMY T7-8, T8-9, T9-10, T10-11, T11-12, T12-L1, L1-2. ANTERIOR INTERBODY ARTHRODESIS T7-8, T8-9, T9-10, T10-11, T11-12, T12-L1, L1-2 . IMPLANTATION OF SPINAL CORRECTION FRA SPACER T11-12, T12-L1, L1-2 INTERSPACE AUGMENTED WITH RHBMP-2 PRE-OP AND POST-OP DIAGNOSIS: POST LAMINECTOMY SYNDROME. ACQUIRED THORACOLUMBAR INSTABILITY WITH KYPHOTIC DEFORMITY. MULTILEVEL THORACIC SPONDYLOSIS WITH MYELOPATHY AS PER OP NOTES: ".. THE INTERSPACE AT T11-12, T12-L1 AND L1-2 WERE THEN SIZED WITH SYNTHES FRA SPACER TRIAL. INTERBODY ARTHRODESIS WAS THEN ACCOMPLISHED AT THESE LEVELS IN A SEQUENTIAL FASHION FIRST STARTING AT L1-2 AND PROCEEDING PROXIMALLY TO T12-L1 AND THEN FINALLY TO T11-12.. THE FRA WAS THEN PREPARED FOR IMPLANTATION. THE CENTRAL CORE WAS FILLED WITH COLLAGEN SPONGE, WHICH HAD BEEN DOSED WITH RHBMP-2... NO COMPLICATIONS WERE REPORTED.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271062 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