BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILOS 3.5 5HO TI

    MDR report key: 2863089 · Received December 10, 2012

    Report

    Report Number
    2520274-2012-03619
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    June 16, 2009
    Report Date
    December 16, 2009
    Manufacturer
    SYNTHES
    Product Code
    KTW
    PMA / PMN Number
    K011815
    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 OCTOBER 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 (B)(6) COMPLAINT HANDLING UNIT REPORTED THAT THE PLATE BROKE. INITIAL OP ON (B)(6) 2009 WITH PHILOS PLATE FOR FRACTURE OF HUMERUS. AN ACCIDENTAL FALL FROM A LADDER ON (B)(6) 2009 RESULTED IN BROKEN PHILOS, PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM PLATE. PATIENT REVISED ON (B)(6) 2009 AND RE-OPERATED WITH AN ANGLED PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS 3.5 5HO TI PHILOS KTW SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention