BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3250468 · Received July 26, 2013

    Report

    Report Number
    1030489-2013-03135
    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.

    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 ON (B)(6) 2009, THE PATIENT UNDERWENT A POSTERIOR APPROACH TLIF AT L5-S1 WHERE A CAPSTONE CAGE WAS PLACED WITH LOCAL BONE FROM LAMINECTOMY AND ALLOGRAFT CHIPS ALL COMBINED WITH RHBMP-2/ACS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT MINIMALLY INVASIVE TLIF L5-S1. PERCUTANEOUS PEDICLE SCREW AT L5-S1. CAGE INSTRUMENTATION L5-S1. LOCAL AUTOGRAFT BONE. PREOPERATIVE DIAGNOSIS: GRADE 1 ISTHMIC SPONDYLOLISTHESIS L5-S1. PER-OP NOTES: ¿CAGE TRIALS WERE PLACED IN THE DISC AND IT WAS FOUND THAT A 26MM LENGTH, 12MM HEIGHT TRIAL FIT WELL. LOCAL BONE OBTAINED FROM A LAMINECTOMY WAS COMBINED WITH ALLOGRAFT BONE CHIPS. LOCAL BONE OBTAINED FROM A LAMINECTOMY WITH MORSELIZED IN A BONE MILL ALONG WITH ALLOGRAFT CHIPS. TWO-THIRDS OF A SMALL RHBMP-2/ACS KIT WAS MORSELIZED AND PACKED INTO THE BONE GRAFT. THE BONE GRAFT WAS IMPACTED THROUGHOUT THE DISC SPACE AND INTO THE CAGE. THE CAGE WAS IMPACTED SO IT WAS WELL CENTERED IN BOTH THE AP AND LATERAL PLANES. THIS COMPLETED TLIF AND CAGE INSTRUMENTATION. ON (B)(6) 2009 THE PATIENT UNDERWENT RIGHT L5, S1 LUMBAR LAMINOTOMY, RIGHT L5 FACETECTOMY, RIGHT L5 PARS RESECTION. PREOPERATIVE DIAGNOSIS: INTERVERTEBRAL DISC DEGENERATIVE AT L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351054 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