BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3212888 · Received July 9, 2013

    Report

    Report Number
    1030489-2013-02979
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    March 28, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    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 THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH 1) CENTRAL AND RIGHT FORAMINAL HERNIATION OF THE L5-S1 DISC. 2) ANNULAR DISRUPTION, L5-S1, WITH MOTION SEGMENT INSTABILITY AT THE L5-S1 LEVEL. 3) MODERATE STENOSIS RIGHT, L5-S1, AND UNDERWENT THE FOLLOWING PROCEDURES: 1) BILATERAL DECOMPRESSIVE LUMBAR LAMINECTOMY AND PARTIAL MEDIAL FACETECTOMIES OF THE L5 AND S1 LEVEL. 2) FORAMINOTOMIES OF THE L5 AND S1 NERVE ROOTS. 3) DISCECTOMY, L5-S1. 4) POSTERIOR LUMBAR INTERBODY FUSION, L5-S1, USING MILLED PROSTHETIC BONE GRAFT. 5) BILATERAL LATERAL MASS FUSION, L5-S1, USING AUTOGENOUS BONE. 6) AUGMENTATION OF LATERAL FUSION MASS BILATERALLY USING A COMBINATION OF BONE MORPHOGENIC PROTEIN WITH BONE GRAFT. 7) SEGMENTAL FIXATION, L5-S1, USING THE TITANIUM PEDICLE SCREW SYSTEM. 8) FLUOROSCOPIC PLACEMENT OF THE PEDICLE SCREWS AT L5 AND S1. 9) INTRAOPERATIVE SPINAL CORD MONITORING. AS PER OP-NOTES, ¿WE DID OUR FINAL IRRIGATION, AND THEN WE RETRACTED ONCE AGAIN VERY DEEP ALONG THE RODS AND SCREWS AND THEN PLACED AND AUGMENTED THE LATERAL F USION TECHNIQUE WITH A COMBINATION OF BONE MORPHOGENIC PROTEIN WITH BONE GRAFT. THIS GAVE US EXCELLENT FILL OF THE ENTIRE LATERAL GUTTER FROM THE TOP OF L5 DOWN THROUGH THE ALUM OF THE SACRUM. THIS WAS ACCOMPLISHED ON BOTH SIDES. ONCE THIS HAD BEEN COMPLETELY PLACED WE PULLED THE MUSCLE BACK TO THE MIDLINE. WE CONTROLLED HEMOSTASIS IN EXCELLENT FASHION. WE PLACED A DRAIN AND BROUGHT IT OUT SUPERIORLY. WE NOW STARTED OUR FINAL CLOSING TECHNIQUE¿. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312616 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 Other