BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4140785 · Received October 3, 2014

    Report

    Report Number
    1030489-2014-03814
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    July 25, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 ON: (B)(6) 2010: THE PATIENT PRESENTED WITH L4-L5, L5-S1 DISKOGENIC PAIN WITH RIGHT L5 RADICULOPATHY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LAMINECTOMY L4-L5, L5-S1. OSTECTOMIES L4-L5, L5-S1. CAGE PLACEMENT L4-L5, L5-S1. ARTHRODESIS OF THE ENDPLATES. POSTEROLATERAL ARTHRODESIS. SEGMENTAL FIXATION L4 TO S1 WITH PEDICLE SCREWS. DRAIN PLACEMENT. FORAMINOTOMIES FOR THE L4, L5 AND S1 NERVE ROOTS. AS PER OP-NOTES, "DISKECTOMY AT L4-L5 AND L5-S1 WAS DONE WITH ALLOGRAFT PLACEMENT, BMP, THE CAGES WERE THEN PLACED AT L4-L5 AND L5-S1." ON (B)(6) 2010: THE PATIENT PRESENTED WITH ANEMIA, PERINEAL BLEEDING, POSSIBLE GI BLEEDING. THE PATIENT UNDERWENT FLEXIBLE SIGMOIDOSCOPY. POST-OP DIAGNOSIS: POOR PREP WITH NO RECTAL BLEEDING. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2010: THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION AT L4-5, L5-S1 USING RHBMP-2/ACS. FOLLOWING THE SURGERY, THE PATIENT SUFFERED SIGNIFICANT PAIN IN THE AREA OF THE FUSION SURGERY AND EXTREMITIES. THE PATIENT UNDERWENT ADDITIONAL IMAGING THAT SHOWED THAT THE PATIENT HAD DEVELOPED BONEY OVERGROWTH. THE PATIENT HAS RECEIVED SIGNIFICANT MEDICAL TREATMENT TO CARE FOR THE INJURIES CAUSED BY THE ORIGINAL FUSION SURGERY. THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY, AND HE HAS DAILY, DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619508 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 Required Intervention