BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191163 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02543
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    December 12, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AND A POSTEROLATERAL LUMBAR INTERBODY FUSION AT L5-S1 USING RHBMP-2 MIXED WITH AUTOGRAFT AND MASTERGRAFT. SOME OF THE MIXTURE WAS PLACED ¿DIRECTLY INTO [THE PATIENT¿S] SPINE WITHOUT ANY CAGE AT ALL¿ AND THE REMAINDER WAS PLACED INTO A PEEK CAGE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH INJURIES, INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED PER PATIENT¿S MEDICAL RECORDS THAT ON: (B)(6) 2010: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: HERNIATED DISC CENTRALLY AND TO THE LEFT L5-S1. HE UNDERWENT THE FOLLOWING PROCEDURES: POSTEROLATERAL FUSION, L5-S1 BILATERALLY. POSTERIOR LUMBAR INTERBODY FUSION, L5-S1. DISKECTOMY WITH FORAMINOTOMY, L5-S1. INSERTION OF PEEK CAGE WITH BMP. INTERNAL FIXATION WITH BMP. INTERNAL FIXATION USING INTERNAL FIXATION. PLATE AUGMENTATION. AUTOGRAFT FOR LAMINECTOMY. CONTINUOUS NEUROELECTROPHYSIOLOGICAL MONITORING DURING THE ENTIRE CASE. PER OP NOTES, ¿¿ONCE THE ENDPLATES WERE REMOVED, A CAGE FILLED WITH BMP WAS PLACED IN THE INTERSPACE AFTER ADEQUATE PREPARATION WAS MADE IN THE INTERSPACE. PRIOR TO DOING THIS, A SMALL AMOUNT OF LOCAL BONE WITH BMP WAS TAKEN AND PLACED INTO THE INTERSPACE¿. DECORTICATION WAS DONE LATERALLY IN THE GUTTERS. BONE THAT HAD BEEN HARVESTED LOCALLY WAS TAKEN AND PLACED LATERALLY AS WELL AS BMP AND BONE GRAFT. PRIOR TO DOING THIS, COPIOUS IRRIGATION WAS DONE. A 30 MM ROD WAS USED TO CONNECT THE POLYAXIAL HEADS¿¿ THE PATIENT TOLERATED THE PROCEDURE WELL AND WENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ON (B)(6) 2010: THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291109 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 00053 YR Required Intervention