BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSORB FX PLATE

    MDR report key: 2598357 · Received February 1, 2008

    Report

    Report Number
    9613278-2008-00013
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 9, 2008
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOSORB FX O/M SYSTEM IS INTENDED FOR USE IN TRAUMA AND RECONSTRUCTIVE PROCEDURES IN THE MIDFACE, MAXILLA AND MANDIBLE. THIS WAS AN OFF LABEL USE.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PLATE AND 8 SCREWS USED TO FIXATE A SINGLE RIB FRACTURE. ON (B)(6) 2007, PT CAME BACK TO THEATRE. THE PLATE HAD BROKEN IN THE MIDDLE. REPLACED WITH ANOTHER DEVICE. PT OUTCOME: NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSORB FX PLATE PLATE, BONE HRS CONMED LINVATEC BIOMATERIALS LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other