BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3503643 · Received December 6, 2013

    Report

    Report Number
    1030489-2013-04912
    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)(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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE PATIENT¿S MEDICAL RECORDS THAT THE PATIENT PRESENTED TO SURGERY WITH RECURRENT DISC HERNIATION AT L5-S1. THE PATIENT UNDERWENT A PROCEDURE FOR POSTEROLATERAL FUSION L5-S1; TLIF L5-S1; PEDICLE SCREW FIXATION AND INTERBODY CAGE L5-S1; ILIAC CREST BONE GRAFT AND RHBMP-2/ACS. IT IS ALLEGED THAT THE PATIENT¿S POST-OPERATIVE PERIODS WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2006 THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: RECURRENT DISC HERNIATION L5-S1. THE PATIENT UNDERWENT: POSTEROLATERAL SPINAL FUSION L5-S1; TRANSFORAMINAL LUMBAR INTERBODY FUSION L5-S1; PEDICLE SCREW INSTRUMENTATION L5-S1; CAGE INSTRUMENTATION L5-S1; RIGHT MAC CREST BONE GRAFT. AS PER OP NOTES, 6.5 MILLIMETER DIAMETER 40 MILLIMETER LENGTH SCREWS WERE PLACED IN THE L5 AND S1 BILATERALLY. LOCAL BONE OBTAINED FROM THE LAMINECTOMY WAS IMPACTED AGAINST THE ANTERIOR ANNULUS AND USED TO FILL THE INTERVERTEBRAL DISC SPACE. THIS WAS COMBINED WITH ONE-QUARTER OF A LARGE RHBMP-2 KIT WHICH WAS PACKED AGAINST THE ANTERIOR ANNULUS. THE 32 MILLIMETER LENGTH, 14 MILLIMETER HEIGHT CAGE WAS THEN IMPACTED INTO THE INTERVERTEBRAL DISC SPACE TO COMPLETE THE TLIF AND CAGE INSTRUMENTATION AT L5-S1. FOLLOWING DECORTICATION OF THE POSTEROLATERAL GUTTERS RHBMP-2 AND ILIAC CREST AUTOGRAFT WAS PLACED OVER THE DECORTICATED POSTERIOR ELEMENTS IN ORDER TO COMPLETE POSTEROLATERAL ARTHRODESIS AT L5-S1. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633201 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 00044 YR Other