BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIMIX

    MDR report key: 454785 · Received April 17, 2003

    Report

    Report Number
    1032347-2003-00005
    Event Type
    Other
    Date Received
    April 17, 2003
    Date of Event
    February 3, 2003
    Report Date
    March 18, 2003
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    GXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INITIAL SURGERY TO PLACE MIMIX, A BONE VOID FILLER. ACCORDING TO PT'S FAMILY MEMBER, MATERIAL NEVER HARDENED, BUT DISSOLVED, LEAVING INDENTIONS IN THE SKULL. IN 2003, REVISION SURGERY PERFORMED TO PLACE HTP IMPLANT. NO ADDITIONAL PROBLEMS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIMIX CALCIUM PHOSPHATE BONE VOID FILLER GXP WALTER LORENZ SURGICAL, INC. * 265700

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other