BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3503748 · Received December 6, 2013

    Report

    Report Number
    1030489-2013-04925
    Event Type
    Injury
    Date Received
    December 6, 2013
    Report Date
    January 26, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    (B)(4).

    Description of Event or Problem · 1

    IMPLANT DATE: (B)(6) 2011 AND (B)(6) 2012. PT DEMOGRAPHICS: GENDER: MALE. INITIALS: (B)(6), PT HISTORY: PATIENT HAS HAD INCAPACITATING BACK AND LEG PAIN RELATED TO A FORAMINAL HERNIATED DISC, WHICH IS CAUSING SEVERE STENOSIS OF HIS L5 NERVE ROOT ON THE LEFT. PATIENT HAS BEEN UNRESPONSIVE TO CONSERVATIVE TREATMENT. (B)(6) 2011: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF A HERNIATED DISC AND INSTABILITY AT L5-S1. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. MINIMALLY INVASIVE TLIF AT L5-S1; 2. PERCUTANEOUS PEDICLE SCREW INSTRUMENTATION, L5-S1; 3. CAGE INSTRUMENTATION, L5-S1; 4. LOCAL AUTOGRAFT BONE. PER THE OP NOTES, LOCAL BONE OBTAINED FROM LAMINECTOMY WAS PACKED AGAINST THE ANTERIOR ANNULUS ALONG WITH 1 PLEDGET OF A MEDIUM RHBMP-2/ACS KIT. TWO PLEDGETS WERE PLACED IN THE CRESCENT CAGE. MASTERGRAFT MATRIX WAS PACKED DORSAL TO THE CRESCENT CAGE. NO COMPLICATIONS WERE REPORTED. (B)(6) 2012: IT WAS REPORTED THAT THE PATIENT DEVELOPED A NON-UNION OF RECURRENT BACK AND LEG PAIN. THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF NON-UNION OF L5-S1 TLIF. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. HARDWARE REMOVAL, EXPLORATION OF FUSION, L5-S1; 2. REVISION OF POSTEROLATERAL SPINAL FUSION, L5-S1; 3. PEDICLE SCREW INSTRUMENTATION, L5-S1; 4. RIGHT ILIAC CREST BONE GRAFT. PER THE OP NOTES, FOLLOWING DECORTICATION OF THE TRANSVERSE PROCESSES OF L5 AND THE SACRAL ALA, ILIAC CREST AUTOGRAFT WAS PACKED INTO THE CENTER OF AN RHBMP-2/ACS SPONGE, WHICH WERE ROLLED ONTO ITSELF INTO A BURRITO AND THE RHBMP-2/ACS AND ILIAC CREST WERE LAID OVER THE DECORTICATED POSTERIOR ELEMENTS. SOLERA 6.5X40 SCREWS WERE PLACED IN L5 AND S1 BILATERALLY. NO COMPLICATIONS WERE REPORTED. THE PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY SEVERE, PAINFUL, AND DEBILITATING COMPLICATIONS WHICH INCLUDED, BUT WERE NOT LIMITED TO, THE NEED FOR ADDITIONAL SURGERY, PAINFUL MEDICAL TREATMENT, EXTREME PAIN, NERVE DAMAGE, NERVE IMPINGEMENT, AND SEVERE EXUBERANT, ECTOPIC BONE FORMATION. THE SEVERE, PAINFUL, AND DEBILITATING COMPLICATIONS WHICH MARKED THE PATIENT'S POST-OPERATIVE PERIOD CONTINUE TO PRESENT DAY AND WILL LIKELY CONTINUE INTO THE FORESEEABLE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2011 THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: HERNIATED DISC AND INSTABILITY, L5-S1. THE PATIENT UNDERWENT: MINIMALLY INVASIVE TLIF AT L5-S1; PERCUTANEOUS PEDICLE SCREW INSTRUMENTATION, L5-S1; CAGE INSTRUMENTATION, L5-S1; LOCAL AUTOGRAFT BONE. AS PER OP NOTES, LOCAL BONE OBTAINED FROM LAMINECTOMY WAS PACKED AGAINST THE ANTERIOR ANNULUS ALONG WITH 1 PLEDGET OF A MEDIUM INFUSE KIT TWO PLEDGETS WERE PLACED IN THE CAGE. THE CAGE WAS IMPACTED AND ROTATED SO THAT IT WAS WELL CENTERED IN BOTH THE AP AND LATERAL PLANES. BONE GRAFT MATRIX WAS PACKED DORSAL TO THIS. THIS COMPLETED THE MINIMALLY INVASIVE TLIF AND CAGE INSTRUMENTATION. THE TUBULAR RETRACTOR WAS THEN WITHDRAWN. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2012 THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: NON-UNION OF L5-S1 TLIF. THE PATIENT DEVELOPED A NON-UNION OF RECURRENT BACK AND LEG PAIN STATUS POST A MINIMALLY INVASIVE TLIF AT L5-S1. THE PATIENT UNDERWENT: HARDWARE REMOVAL, EXPLORATION OF FUSION L5-S1; REVISION OF POSTEROLATERAL SPINAL FUSION, L5-S1; PEDICLE SCREW INSTRUMENTATION L5-S1; RIGHT ILIAC CREST BONE GRAFT. AS PER OP NOTES, A REVISION POSTEROLATERAL ARTHRODESIS WAS PERFORMED AS FOLLOWS. THE TRANSVERSE PROCESSES OF L5 AND THE SACRAL ALA WERE DECORTICATED. ILIAC CREST AUTOGRAFT WAS PACKED INTO THE CENTER OF AN RHBMP-2 SPONGE, WHICH WERE ROLLED ONTO ITSELF INTO A BURRITO AND THE RHBMP-2 AND ILIAC CREST WERE LAID OVER THE DECORTICATED POSTERIOR ELEMENTS. NO PATIENT COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632888 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Other| R