BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODEGRADABLE INION OTPS BIOABSORBABLE FIXATION SYSTEM

    MDR report key: 609393 · Received May 31, 2005

    Report

    Report Number
    3003547707-2005-00005
    Event Type
    Malfunction
    Date Received
    May 31, 2005
    Report Date
    May 26, 2005
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANKLE OPERATION WITH BIODEGRADABLE SCREWS AND PLATE. TWO WEEKS AFTER OPERATION PAIN IN ANKLE REOPERATION, SCREWS AND PLATES REMOVED. UNK THE MATERIAL USED IN REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODEGRADABLE INION OTPS BIOABSORBABLE FIXATION SYSTEM BONE, ANKLE SCREWS HWC INION LTD. FRF-1245 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other