BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2132281 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00745
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    August 23, 2010
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS. THE PATIENT UNDERWENT A SECOND OPERATION FOR POSTERIOR HARDWARE REMOVAL AND ALIF AT L4-5, L5-S1 WITH INTERBODY CAGES, RHBMP-2/ACS, LOCAL BONE, AND ALLOGRAFT AND POSTERIOR FUSION/INSTRUMENTATION AT L4-S1. ONE LARGE SPONGE WITH RHBMP-2 WAS USED IN THE ALIF PROCEDURE. THE REMAINING LARGE SPONGE WAS USED FOR THE POSTERIOR FUSION AND PLACED OVER THE POSTEROLATERAL GUTTER. FOUR DAYS POST-OP THE PATIENT REPORTED SEROSANGUINEOUS DRAINAGE AT THE POSTERIOR INCISION SITE AND LOW GRADE FEVER. ON (B)(6) 2010 THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT FOR SUPERFICIAL WOUND SEROMA. CULTURES WERE NEGATIVE AND PATIENT WAS DISCHARGED ON VANCOMYCIN. MRI TAKEN ON (B)(6) 2010 REVEALED A FLUID COLLECTION SUPERFICIAL TO THE SPINAL MUSCULATURE (POSSIBLE SEROMA) AND A SECOND DEEPER COLLECTION ADJACENT TO THE POSTERIOR ASPECT OF THE LAMINECTOMY SITE. ON (B)(6) 2010 THE PATIENT UNDERWENT A SECOND IRRIGATION AND DEBRIDEMENT. CULTURES TAKEN DURING THE PROCEDURE GREW PROPIONIBACTERIUM AND THE PATIENT WAS STARTED ON IV ANTIBIOTICS VIA PICC LINE AND WAS LATER DISCHARGED ON VANCOMYCIN. ON (B)(6) 2010 THE PATIENT PRESENTED TO THE ER WITH POSSIBLE PICC LINE INFECTION AND RENAL FAILURE. RENAL FAILURE WAS FELT TO BE CAUSED BY ACUTE TUBULAR NECROSIS IN THE SETTING OF VANCOMYCIN TOXICITY. PICC LINE WAS DETERMINED TO BE NOT INFECTED. PATIENT WAS THEN STARTED WITH ORAL CLINDAMYCIN FOR THE HISTORY OF PROPIONIBACTERIUM INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC M110812AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R