BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140604 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02039
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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) 2007 PATIENT PRESENTS WITH LOW BACK PAIN, LUMBAGO WITH LOWER EXTREMITY RADICULOPATHY. ON (B)(6) 2007 L1-S1 LUMBAR PROVOCATIVE DISCOGRAPHY AND EPIDURAL INJECTIONS AT L1-S1 (B)(6) 2007 SURGERY: L4-S1 POSTEROLATERAL ARTHRODESIS, LAMINECTOMY AND FORAMINOTOMY, FACETECTOMY AND DECOMPRESSION (TLIF). FRONTAL AND LATERAL VIEW OF LUMBAR SPINE WITH PEDICLE SCREWS FUSING SEGMENTS FROM L4-S1. ON (B)(6) 2007 FOLLOW-UP FUSION / FOUR VIEWS OF LUMBAR SPINE L4-S1. ¿STABLE FUSION¿ EVIDENT. ON (B)(6) 2008 FOLLOW-UP FUSION / FOUR VIEWS OF LUMBAR SPINE L4-S1. ¿STABLE FUSION¿ EVIDENT. ON (B)(6) 2008 PAIN IN LOWER BACK. DISC SPACE NARROWING EVIDENT ON X-RAYS, MOST SEVERE AT L3-4 AND L4-5, CONSISTENT WITH DDD. ON (B)(6) 2008 FOUR VIEW X-RAYS OF LUMBAR SPINE. DISC HEIGHT LOSS AT L3-4. %MM POSTERIOR SUBLUXATION ON L2 ON L3 IS NOTED WITH SLIGHT NARROWING OF THE POSTERIOR ASPECT OF THAT DISC SPACE. SMALL ENDPLATE OSTEOPHYTES THROUGHOUT LUMBAR SPINE. ON (B)(6) 2008 BONE DENSITOMETRY, FINDINGS: OSTEOPENIA. CT SCAN, ¿AREAS OF LUCENCY MOST LIKELY RELATED TO THE USE OF BONE MORPHOGENETIC PROTEIN¿; LYTIC CHANGES IN L4 FACET; L4-5 NARROWING OF LEFT NEURAL FORAMEN; LUCENT CHANGES ERODED LEFT FACET JOINTS. MRI LUMBAR SPINE, ¿CENTRAL CANAL AND NEURAL FORAMINAL STENOSIS¿. ON (B)(6) 2009 X-RAYS, ¿INTERVAL REMOVAL OF PEDICLE SCREWS IN L4, L5 AND S1 LEVELS.¿ PATIENT ADMITTED INTO HOSPITAL FOR ¿FAILED BACK SYNDROME¿ AND SYMPTOMS SECONDARY TO DEGENERATIVE DISC DISEASE AND ¿L5-S1 PSEUDOARTHROSIS WITH POSTERIOR HARDWARE FAILURE.¿ DECOMPRESSION SURGERY (REVISION) OF L4-5 AND L5-S1 PERFORMED USING ¿BIOMECHANICAL SYNTHETIC CAGE AS WELL AS DEMINERALIZED BONE MATRIX, BETA TRICALCIUM PHOSPHATE AS WELL AS PRODUCTS OF AUTO GRAFT AND ALLOGRAFT. EXPLORATION AND REIMPLANTATION OF POSTERIOR HARDWARE W/ DECOMPRESSION OF FORAMEN AND CENTRAL CANAL.¿ ON (B)(6) 2009 PATIENT DISCHARGED. ON (B)(6) 2009 X-RAYS LUMBAR SPINE (B)(6) 2009 X-RAYS LUMBAR SPINE SHOW ¿STABLE FUSION¿ (B)(6)2009 X-RAYS LUMBAR SPINE ¿OVERALL STABLE LUMBAR SPINAL FUSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241011 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110606AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention