BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE HUMERAL

    MDR report key: 2870478 · Received December 12, 2012

    Report

    Report Number
    2520274-2012-03887
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH MEDIAL AND LATERAL VA LCP DISTAL HUMERUS PLATES AND SCREWS, IMPLANTED FOR AN INTRA ARTICULAR FRACTURE, ON (B)(6) 2012. PATIENT RETURNED TO SURGEON FOR FOLLOW UP VISIT ON AN UNKNOWN DATE; X-RAYS SHOWED THE FRACTURE HAD SHIFTED AND TWO SCREWS BACKED OUT OF THE PLATE. NO PLANNED INTERVENTION SCHEDULED AT THE TIME OF THIS REPORT. HARDWARE WILL BE LEFT AS IS IN HOPES OF CONTINUED HEALING. THERE WAS MINIMAL IRRITATION FOR THE PATIENT. NO TREATMENT IS SCHEDULED AT THIS TIME. THIS IS 1 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE HUMERAL HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE, SCREW