BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRO OSTEON 500R RESORBABLE BONE GRAFT SUBSTITUTE

    MDR report key: 561937 · Received December 28, 2004

    Report

    Report Number
    2029012-2004-00071
    Event Type
    Other
    Date Received
    December 28, 2004
    Date of Event
    July 12, 2004
    Report Date
    December 28, 2004
    Manufacturer
    INTERPORE CROSS INTL.
    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. PRE-OP DIAGNOSIS-PROGRESSIVE INFANTILE ILIOPATHIC SCOLIOSIS. PROCEDURE-POSTERIOR LATERAL LUMBAR FUSION T3-L2 WITH INSTRUMENTATION (STRYKER XIA SYSTEM WITH INTERGRO PUTTY AND PRO OSTEON 500R). PATIENT DEVELOPED INFECTION 4 DAYS POSTOP. INFECTION TREATED WITH ANTIBIOTICS-GENTAMYCIN, VANCOMYCIN, CIPRO. IRRIGATION AND DEBRIDEMENT PERFORMED THREE DAYS LATER-ALL INTERGRO DBM AND PRO OSTEON 500R WAS REMOVED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON 500R RESORBABLE BONE GRAFT SUBSTITUTE BONE GRAFT SUBSTITUTE MQV INTERPORE CROSS INTL. NA 305801

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O