BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERGRO DBM PUTTY

    MDR report key: 537824 · Received August 5, 2004

    Report

    Report Number
    2029012-2004-00028
    Event Type
    Other
    Date Received
    August 5, 2004
    Date of Event
    July 12, 2004
    Report Date
    August 5, 2004
    Manufacturer
    INTERPORE CROSS INTERNATIONAL
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL SURGERY 2004. PREOP DIAGNOSIS - PROGRESSIVE INFANTILE ILIOPATHIC SCOLIOSIS. PROCEDURE - POSTERIOR LATERAL LUMBAR FUSION T3-L2 WITH INSTRUMENTATION (STRYKER XIA SYSTEM WITH INTERGRO PUTTY). PT DEVELOPED INFECTION 4 DAYS POSTOP. INFECTION TREATED WITH ANTIBIOTICS - GENTAMICIN, VANCOMYCIN, CIPRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGRO DBM PUTTY DEMINERALIZED BONE MATRIX MQV INTERPORE CROSS INTERNATIONAL NA 034617

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R