BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMED 13 HOLE LOCKING OLECRANON PLATE

    MDR report key: 2013229 · Received March 10, 2011

    Report

    Report Number
    3025141-2011-00008
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IMPLANTED AND THERE ARE CURRENTLY NO PLANS TO EXPLANT DEVICE. SPECIFIC LOT INFORMATION WAS NOT PROVIDED AND NO DEVICE WAS AVAILABLE FOR EVALUATION. THEREFORE NO DEFINITIVE CONCLUSION CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE SALES REPRESENTATIVE, THE SURGERY TO IMPLANT AN ACUMED 13 HOLE LOCKING OLECRANON PLATE (PL-LEO13) ON (B)(6) 2011 WENT SMOOTHLY AND THERE WERE NO ISSUES DURING THE IMPLANTATION OF THE PLATE OR SCREWS. NO AUGMENTATIONS WERE MADE TO THE ITEMS THAT WERE USED IN SURGERY; MEANING THE PLATE WAS NOT BENT OR ADJUSTED IN ANY WAY. THE PATIENT'S ARM AND ELBOW WERE PLACED IN A CAST AFTER THE SURGERY. ON (B)(6) 2011, THE SURGEON CALLED THE SALES REPRESENTATIVE TO INFORM HIM THAT THE PATIENT HAD RETURNED TODAY ((B)(6) 2011) FOR A FOLLOW UP APPOINTMENT, AND X-RAYS WERE TAKEN OF THE FRACTURE. UPON EXAMINATION OF THE FRACTURE, THE SURGEON DISCOVERED THE PLATE, A PL-LEO13, WAS BROKEN INSIDE THE PATIENT'S BODY. ACCORDING TO THE SURGEON, THE PLATE WAS BROKEN COMPLETELY SO THE PLATE IS IN TWO PIECES. THE SCREWS ARE STILL LOCKED IN PLACE, HOWEVER THE PLATE WAS BROKEN ABOUT 3CM FROM THE FRACTURE IN THE BONE. THERE ARE NO PLANS TO EXPLANT THE DEVICE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    UPDATE: REVISION SURGERY WAS COMPLETED ON (B)(6) 2011 WHERE THE BROKEN PLATE WAS EXPLANTED AND REPLACED WITH A DIFFERENT PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED 13 HOLE LOCKING OLECRANON PLATE BONE PLATE HRS ACUMED LLC PL-LEO13 W55344

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention