BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3250514 · Received July 26, 2013

    Report

    Report Number
    1030489-2013-03136
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    March 14, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010 THE PATIENT UNDERWENT: HARDWARE REMOVAL AND EXPLORATION OF FUSION L5-S1. POSTEROLATERAL SPINAL FUSION L5-S1. PEDICLE SCREW INSTRUMENTATION L5-S1. RIGHT ILIAC CREST BONE. PREOPERATIVE DIAGNOSIS: PSEUDOARTHROSIS L5-S1 AT PRIOR FUSION. PER-OP NOTES: ¿ WE DECORTICATED THE TRANSVERSE PROCESSES OF L5 AND SACRAL ALA. A LARGE RHBMP-2/ACS KIT WAS PREPARED ACCORDING TO MANUFACTURER¿S INSTRUCTIONS. IT WAS CUT IN HALF AND THE ILIAC CREST AUTOGRAFT WAS STUFFED INTO THE RHBMP-2 SPONGES WHICH WERE ROLLED ONTO THEMSELVES AND THESE WERE PACKED WITH THE DECORTICATED POSTERIOR ELEMENTS IN ORDER TO COMPLETE A POSTEROLATERAL ARTHRODESIS AT L5-S1. THEN 6.5MM DIAMETER 40MM LENGTH SOLERA SCREWS WERE PLACED AT L5 AND S1 BILATERALLY.¿ ON (B)(6) 2011 THE PATIENT UNDERWENT A REVISION SURGERY OF FORAMINOTOMIES AT L5-S1. HE HAD A PREVIOUS LUMBAR FUSION AT L5-S1, BUT UNFORTUNATELY HAD BONE THAT HAD GROWN OUT OF HIS INTRADISCAL SPACE INTO THE FORAMEN, PINCHING THE NERVE ROOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A POSTERIOR FUSION USING RHBMP-2/ACS. ON (B)(6) 2011, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BONE OVERGROWTH FROM THE L5-S1 SPACE INTO THE FORAMEN, PINCHING THE NERVE ROOT. IMAGING STUDIES REPORTEDLY SHOWED THAT THE PATIENT HAD DEVELOPED UNCONTROLLED BONE GROWTH (AKA "BONE OVERGROWTH") AND RESULTING NERVE COMPRESSION AT OR NEAR WHERE THE BMP WAS IMPLANTED. THE PATIENT NOW SUFFERS FROM SEVERE INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO CHRONIC PAIN AND RADICULITIS, AND EMOTIONAL DISTRESS AND MENTAL ANGUISH. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350087 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention