BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP(TM) DISTAL RADIUS PLATEVOLAR/RIGHT-LONG

    MDR report key: 2842908 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03329
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    April 8, 2009
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    K091644
    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

    (B)(6) REPORTED A BROKE AND BENT PLATE. THE CASE WAS CLOSED DUE TO LACK OF INFORMATION. THE CASE WAS REOPENED ON (B)(4) 2009, AS NEW INFORMATION WAS MADE AVAILABLE. AN X-RAY WAS ALSO AVAILABLE. ONE BROKEN AND ONE BENT PLATE DURING THE LAST 3 WEEKS. THE SURGEON STATED THAT HE DID NOT PREBEND ANY PLATE AT ALL. THE FIRST OPERATION WAS (B)(6) 2009. THE SECOND OPERATION WAS (B)(6) 2009. THE THIRD OPERATION WAS (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LCP(TM) DISTAL RADIUS PLATEVOLAR/RIGHT-LONG TI LCP(TM) DISTAL HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention