BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191340 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02548
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    September 26, 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. 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.

    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 THAT THE PATIENT UNDERWENT AN L4-S1 FUSION VIA A POSTEROLATERAL APPROACH, USING RHBMP-2/ACS AT MULTIPLE LEVELS, MIXING RHBMP-2/ACS WITH AUTOGRAFT AND A HYDROXYAPATITE SPONGE, AND IMPLANTING RHBMP-2/ACS WITH A INTERBODY SPACER. IT WAS REPORTED THAT THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH INJURIES INCLUDING ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REPORTED CONTINUED DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT WAS ADMITTED TO THE HOSPITAL. ADMISSION DIAGNOSIS: INTRACTABLE LOW BACK PAIN DUE TO DEGENERATIVE DISC DISEASE AT L4-5 AND L5-S1. ASSESSMENTS: HE WAS STATUS POST THREE PRIOR LUMBAR PROCEDURES. ALTHOUGH HIS RIGHT LEG PAIN HAS IMPROVED WITH MEDICAL PAIN MANAGEMENT, HE CONTINUES TO SUFFER FROM INTRACTABLE MECHANICAL LOW BACK PAIN. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: LUMBOSACRAL FUSION; EXCISION OF INTERVERTEBRAL DISC; EXCISION OF INTERVERTEBRAL DISC; EXCISION OF BONE GRAFT, EXCEPT FACIAL BONE; FUSION OR REFUSION OF 2-3 VERTEBRAE; INSERTION OF INTERBODY SPINAL FUSION DEVICE; INSERTION OF RECOMBINANT BONE MORHOGENIC PROTEIN. ON (B)(6) 2010 THE PATIENT UNDERWENT: MINIMALLY INVASIVE TRANSFORAMINAL DISCECTOMIES/INTERBODY ARTHRODESIS AT L4-5 AND L5-S1 SUPPLEMENTED WITH PERCUTANEOUS PEDICLE SCREW INSTRUMENTATION AND POSTEROLATERAL ARTHRODESIS. PREOPERATIVE DIAGNOSIS: INTRACTABLE MECHANICAL LOW BACK PAIN DUE TO DISC DISEASE AT L4-5 AND L5-S1. PER-OP NOTES: ¿THE SPACE WAS FOUND SUITABLE FOR AN INTERBODY SPACER OF 12MM IN HEIGHT AND 26MM IN LENGTH. BEFORE PLACING THE SPACER, COLLAGEN SPONGE IMPREGNATED WITH BONE MORPHOGENIC PROTEIN AND CHIPS OF AUTOLOGOUS BONE WERE PACKED ALONG THE ANTERIOR ANNULUS OF THE DISC. THE SPACER WAS ALSO ALSO PACKED WITH BMP AND AUTOLOGOUS BONE¿ A LEFT L4-5 POSTEROLATERAL ARTHRODESIS WAS PERFORMED BY PACKING THE GUTTER WITH COLLAGEN SPONGE IMPREGNATED WITH BONE MORPHOGENIC PROTEIN, CHIPS OF AUTOLOGOUS BONE, AND A BONE GRAFT HYDROXYAPATITE SPONGE.¿ ON (B)(6) 2010 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DISCHARGE DIAGNOSIS: STATUS POST MINIMALLY INVASIVE TRANSFORAMINAL DISCECTOMIES AND INTERBODY ARTHRODESIS AT L4-5 AND L5-S1 SUPPLEMENTED WITH PERCUTANEOUS PEDICLE SCREW INSTRUMENTATION AND POSTEROLATERAL ARTHRODESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289839 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110806AAK

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention