BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4223622 · Received November 4, 2014

    Report

    Report Number
    1030489-2014-04203
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    March 21, 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2012: PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF L5-S1 SPONDYLOLYTIC SPONSYLOLISTHESIS, L5-S1 STENOSIS, LUMBAR RADICULOPATHY AND INTRACTABLE BACK AND LOWER EXTREMITY PAIN AND UNDERWENT FOLLOWING PROCEDURES: LEFT SIDED TRANSFORAMINAL LUMBAR INTER-BODY FUSION (L5-S1); RIGHT SIDED TRANSPEDICULAR EXPOSURE FOR NEURAL DECOMPRESSION (L5-S1); PLACEMENT OF CAGE(L5-S1); POSTERIOR SEGMENTAL INSTRUMENTATION WITH BILATERAL PERCUTANEOUS PEDICLE SCREWS AT L5 AND S1; POSTERIOR SPINAL FUSION (L5-S1); HARVEST OF LOCAL BONE AUTO GRAFT; PLACEMENT OF OSTEOPROMOTIVE MATERIAL (RHBMP-2). INDICATIONS: DIAGNOSTIC STUDIES (X-RAYS AND MRI) SHOWED BILATERAL L5 PARS DEFECTS WITH DISC DESSICATION AT L5-S1/THERE APPEAR TO BE A SLIGHT ANTEROLISTHESIS OF L5 ON S1. THE PATHOLOGY RESULTED IN SUBARTICULAR AND NEURAL FORAMINAL NARROWING. PER OPERATIVE REPORT : ¿¿.. LOCAL AUTOLOGOUS BONE WAS PACKED ANTERIORLY IN THE DISC SPACE ALONG WITH PLEDGET OF BMP. THE 12 X 29 MM DEVICE ITSELF WAS THEN INSERTED WHICH HAD BEEN FILLED WITH BMP ALONG WITH SOME MORE LOCAL BONE AUTOGRAFT. THE BMP WAS USED IN THE INTERBODY SPACE.¿ NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT-SIDED TLIF AT L5-S1 WITH THE PLACEMENT OF INTERBODY DEVICE AT L5-S1 AND A POSTERIOR SPINAL FUSION L5-S1 WITH THE PLACEMENT OF RHBMP-2. IT WAS REPORTED THAT IMAGING STUDIES SHOWED THAT THE PATIENT HAD DEVELOPED UNCONTROLLED BONE GROWTH AND RESULTING NERVE COMPRESSION AT OR NEAR WHERE THE RHBMP-2 WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT NOW EXPERIENCES SEVERE INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO CHRONIC PAIN, RADICULITIS, EMOTIONAL DISTRESS, AND MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707934 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 Other