BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3923869 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03192
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    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

    IMPLANT DATE: (B)(6) 2007. (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 IN (B)(6) 2006, PATIENT UNDERWENT A CERVICAL FUSION PROCEDURE AT AN UNKNOWN LEVEL USING RHBMP-2/ACS WITH THE INSTALLATION OF ¿GROWING RODS¿ TO CORRECT THE KYPHOSIS AND STABILIZE THE SPINE. ACCORDING TO PATIENT'S MOTHER, WHEN THE PATIENT CAME OUT OF SURGERY THE SCREWS THAT SURGEON HAD IMPLANTED WERE SO LONG THEY LOOKED TO BE PRESSING THROUGH PATIENT'S SKIN. PATIENT WAS ONLY A (B)(6) AT THE TIME. WITHIN 24 HOURS, PATIENT HAD TO HAVE EMERGENCY SURGERY; THE ¿GROWING RODS¿ HAD BROKEN AND THE SCREWS HOLDING THE RODS IN PLACE HAD COME THROUGH PATIENT'S SKIN. SURGEON PERFORMED EMERGENCY SURGERY TO REMOVE THE BROKEN RODS AND REPLACE WITH A SINGLE ROD RUNNING FROM PATIENT'S MID-THORACIC REGION TO AN IMPLANTED PLATE AT THE BASE OF HIS SKULL. FOLLOWING THIS EMERGENCY SURGERY, NEUROSURGEONS PLACED THE PATIENT IN A ¿HALO¿ DEVICE THAT HE WOULD WEAR FOR THE NEXT YEAR; FOUR MONTHS OF THAT YEAR WOULD BE SPENT IN A COMA. IN (B)(6) 2007, PATIENT UNDERWENT A POSTERIOR SPINAL FUSION COINCIDING WITH THE REMOVAL OF THE ¿HALO¿ DEVICE AND THE REPLACEMENT OF THE PREVIOUSLY IMPLANTED ROD USING RHBMP-2/ACS. FOLLOWING THE SURGERY, PATIENT IS UNABLE TO MOVE HIS HEAD UP AND DOWN OR SIDE TO SIDE. THIS AFFECTS HIS ABILITY TO VISUALIZE HIS SURROUNDINGS AND INTERACT WITH HIS ENVIRONMENT. PATIENT ALSO HAS ISSUES WITH SKIN BREAKDOWN RELATED TO THE MULTIPLE SURGICAL PROCEDURES AND ¿HALO¿ USE THAT HAVE LED TO EXTENSIVE SCARRING. PATIENT HAS POTENTIALLY STUNTED GROWTH RELATED TO THE SURGICAL PROCEDURES PERFORMED AT SUCH A YOUNG AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401692 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