BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM TI INTERMEDIATE LOCKING PLATE 12 HOLES

    MDR report key: 2831963 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03038
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    February 2, 2009
    Manufacturer
    SYNTHES
    Product Code
    JEY
    PMA / PMN Number
    K974555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE DISTAL PLATE, 447.102, BROKE. THE PLATE AND SCREWS WERE REMOVED AND REPLACED WITH A NEW FIXATION WITH A MALLOT SPLINT. THE PROXIMAL TWO HOLE PLATE REMAINED IN THE PATIENT. AN XRAY WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0MM TI INTERMEDIATE LOCKING PLATE 12 HOLES 2.0MM TI INTERMEDIATE PLATE JEY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention