BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM

    MDR report key: 2972011 · Received February 21, 2013

    Report

    Report Number
    3003506883-2013-00062
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF FINISHED PRODUCT RAW MATERIAL AND DEVICE HISTORY RECORDS DETERMINED THAT THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE, WITH NO IRREGULARITIES DOCUMENTED DURING MANUFACTURING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT CONDITION. 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 ON AN UNKNOWN DATE WITH VA LCP PLATE AND SCREWS. DURING A FOLLOW UP VISIT, DATE UNKNOWN, THE SURGEON NOTED THAT THE WOUND HAD BROKEN DOWN, LOOKED RED AND THE PLATE WAS SHOWING. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2013, HARDWARE WAS REMOVED. SURGEON INITIALLY THOUGHT THERE WAS AN INFECTION, HOWEVER, WHEN HE OPENED THE INCISION THERE WAS NO INFECTION DETECTED. THE SURGEON WAS HAPPY WITH HOW THE WOUND LOOKED AND PERFORMED AN I & D PROCEDURE. THE HARDWARE WAS NOT REPLACED AND THE SURGERY WENT FINE. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL FACILITY. THIS IS 1 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75987 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM VA-LCP OLECRANON PLATE HRS SYNTHES ELMIRA 7039478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention