BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST FLAP CRANIAL FIXATION SYSTEM

    MDR report key: 237338 · Received August 16, 1999

    Report

    Report Number
    2027754-1999-00001
    Event Type
    Malfunction
    Date Received
    August 16, 1999
    Date of Event
    July 23, 1999
    Report Date
    August 10, 1999
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 2/8/99 THE PT HAD A CRANIOPLASTY PERFORMED. THE CRANIAL BONE FLAP WAS FIXATED WITH MULTIPLE BONE SCREWS AND PLATES. TWO OF THE TEN PLATES HAD BEEN IDENTIFIED AS BENT ALLOWING A PORTION OF THE BONE FLAP TO RETRUDE IN THE SURGICAL SITE AREA. THE SURGEON COMPLETED CORRECTIVE SURGERY ON 7/23/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST FLAP CRANIAL FIXATION SYSTEM Implant BONE FIXATION PLATE HRS OSTEOMED CORP. 218-0030 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R