BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3864232 · Received June 10, 2014

    Report

    Report Number
    1030489-2014-02725
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    February 13, 2017
    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. 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

    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.

    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) 2010: THE PATIENT PRESENTED WITH L4-L5 AND L5-S1 STENOSIS, SPONDYLOLISTHESIS AND INSTABILITY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES- 360 FUSION FROM L4 TO S1: ARTHRODESIS, INTERBODY TYPE AT L4-L5 AND L5-S1; ARTHRODESIS, POSTEROLATERAL TYPE, AT L4-S1; BILATERAL L4 AND L5 LAMINOTOMIES, PARTIAL FACECTOMIES AND FORAMINOTOMIES; RIGHT L4-L5 AND L5-S1 DISCECTOMIES WITH CAGE PLACEMENT AT EACH LEVEL; SEGMENTAL PEDICLE SCREW FIXATION FROM L5 TO S1 UTILIZING PEEK RODS; USE OF BMP AND ALLOGRAFT; STEALTH FRAMELESS STEREOTAXY. AS PER-OP NOTES, ¿LAMINOTOMIES, PARTIAL FACETECTOMIES AND FORAMINOTOMIES WERE PERFORMED BILATERALLY AT L4-L5 AND L5-S1 LEVELS, MORE ON THE RIGHT AT THESE LEVELS. STRIPS OF BMP WERE LAYERED IN THE GUTTERS. THIS WAS COVERED WITH ALLOGRAFT, WHICH HAD BEEN MIXED WITH A BONY GLURRY FROM THE BODY REACTION. DISCECTOMY WAS PERFORMED ON THE RIGHT AT L4-L5 AND IMPACTORS WERE IMPACTED TANGENTIALLY ACROSS THE DISC SPACE. A BMP SPONGE WITH ALLOGRAFT WAS PACKED ANTERIORLY AND ACROSS THE MIDLINE. THE CAGE WAS THEN IMPACTED IN A TLIF FASHION. THE CAGE WAS THEN PACKED WITH A BMP SPONGE. THE PROCEDURE WAS REPEATED AT L5-S1 AND A 10 * 22 MM CAGE WAS UTILIZED. ONCE AGAIN AT L4-L5, A 12*22 MM CAGE WAS UTILIZED¿. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN LUMBAR FUSION SURGERY AT L4-S1 USING RHBMP-2/ACS ON (B)(6) 2010. THE SURGEON PERFORMED A TRANSFORAMINAL INTERBODY FUSION AT L4-S1 USING A CAGE THAT WAS PACKED WITH BONE MORPHOGENETIC PROTEIN AND PLACED ANTERIORLY AND ACROSS THE MIDLINE. ADDITIONALLY, STRIPS OF BMP WERE LAYERED IN THE GUTTERS IN A POSTEROLATERAL FUSION AT THE SAME LEVELS. FOLLOWING HER SURGERY, PATIENT INITIALLY IMPROVED, BUT SUBSEQUENTLY DEVELOPED PROGRESSIVE PAIN IN HER BACK AND LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337609 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110908AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| S