BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP PROXIMAL HUMERUS PLATE 4H HEAD/8H SHAFT

    MDR report key: 2856933 · Received December 4, 2012

    Report

    Report Number
    2520274-2012-03594
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    March 16, 2009
    Report Date
    October 21, 2009
    Manufacturer
    SYNTHES
    Product Code
    KTT
    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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES KTW. 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

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A BROKEN PLATE. THE PLATE WAS INSERTED IN THE LEFT SHOULDER ON (B)(6) 2008. ON (B)(6) 2009, THE PATIENT FELT PAIN IN HER SHOULDER. AN X-RAY SHOWED A BREAKAGE OF THE PLATE. ON (B)(6) 2009, THE PLATE WAS REPLACED WITH ANOTHER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI LCP PROXIMAL HUMERUS PLATE 4H HEAD/8H SHAFT 3.5MM TI LCP PROXIMAL HUMERUS KTT SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention