BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON MATRIX PLF

    MDR report key: 2496268 · Received March 14, 2012

    Report

    Report Number
    2246640-2012-00004
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 30, 2011
    Manufacturer
    OSTEOTECH, INC
    Product Code
    MBP
    PMA / PMN Number
    K051195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS WERE REVIEWED AND INDICATED THAT THE SUBJECT LOT OF PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE MFG OF THE PRODUCT, AND THERE WERE NO IRREGULARITIES ASSOCIATED WITH MFG. NEITHER THE DEVICE NOR ANY FILMS OF APPLICABLE IMAGING STUDIES WERE PROVIDED BY THE INITIAL RPTR. THE DEFINITIVE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A 2-LEVEL FUSION (L2-L4), THE SURGEON PLACED DBM BONE VOID FILLER INSIDE THE PEEK CAGE AS WELL AS IN THE DISC SPACE ANTERIOR TO THE CAGE. AT TWO WEEKS POST-OP, THE CAGE HAD MIGRATED POSTERIORLY. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE CAGE WAS REMOVED AND REPLACED ON THE CONTRA-LATERAL SIDE WITH A SMALLER SIZE CAGE. THE DBM GRAFT MATERIAL WAS REMOVED FROM THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON MATRIX PLF DEMINERALIZED BONE MATRIX ALLOGRAFT MBP OSTEOTECH, INC 2.5 X 5CM OTSLN0812224037

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R PEEK CAGE AND RODS