BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIOFIX TITANIUM CLAMP STERILE

    MDR report key: 226028 · Received June 3, 1999

    Report

    Report Number
    2916714-1999-00012
    Event Type
    Injury
    Date Received
    June 3, 1999
    Date of Event
    February 25, 1999
    Report Date
    June 2, 1999
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GXR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INITIAL SURGERY ON 02/10/1999: FRONT TEMPORAL CRANIOTOMY FOR EVACUATION OF SUBDURAL HEMATOMA. PT WAS BROUGHT BACK ON 02/25/1999 FOR EXAM; XRAYS SHOWED CRANIOFIX CLAMP WAS SEPARATED FROM THE SHAFT. RE-OPERATION PERFORMED ON 02/25/1999 TO REMOVE BROKEN CLAMP. PT'S CONDITION POST-OP REPORTED TO BE "MODERATE", BUT NOT COMPROMISED BY THE EVENT, AND HE WAS DISCHARGED TO A REHABILITATION FACILITY. THIS EVENT TYPE IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE NORMAL FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIOFIX TITANIUM CLAMP STERILE Implant BURR HOLE COVER GXR AESCULAP AG & CO. KG NA 51001182

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention