BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11 HOLE LOCKING OLECRANON PLATE

    MDR report key: 4600941 · Received March 13, 2015

    Report

    Report Number
    3025141-2015-00046
    Event Type
    Injury
    Date Received
    March 13, 2015
    Report Date
    February 25, 2015
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2015-00047: SCREW 1; MDR 3025141-2015-00048: SCREW 2; MDR 3025141-2015-00049: SCREW 3; MDR 3025141-2015-00050: SCREW 4; MDR 3025141-2015-00051: SCREW 5; MDR 3025141-2015-00052: SCREW 6; MDR 3025141-2015-00053: SCREW 7.

    Additional Manufacturer Narrative · 1

    PLATE WAS RECEIVED AND EXAMINED BOTH VISUALLY AND UNDER MAGNIFICATION. THE THICKNESS OF THE PLATE WAS FOUND TO BE .(B)(6) WHICH IS WITHIN TOLERANCE OF .169 +/- .005 AND THE WIDTH OF THE PLATE WAS FOUND TO BE .(B)(6) WHICH IS WITHIN TOLERANCE OF .400 +/-.0125. A FRACTURE WAS NOTED THROUGH THE PROXIMAL SLOT. THE FRACTURE SURFACE OF THE PLATE WAS FOUND TO BE SMOOTH, INDICATING THAT PLATE BREAKAGE HAD OCCURRED A PERIOD OF TIME BEFORE EXPLANTATION, AND HAD UNDERGONE A NUMBER OF CYCLES WHILE STILL INSTALLED. THESE CYCLES RUBBED THE FRACTURE SURFACES TOGETHER, CREATING THIS SMOOTHING EFFECT. DUE TO THE SMOOTH FRACTURE SURFACE, IT CANNOT BE DETERMINED IF THIS WAS A BRITTLE FRACTURE OR A FATIGUE FRACTURE. WITHOUT ADDITIONAL INFORMATION, A DEFINITIVE CONCLUSION CANNOT BE DRAWN. CONCLUSION - A CONCLUSION CANNOT BE DRAWN BASED ON THE LACK OF INFORMATION CONCERNING THE CIRCUMSTANCES OF THIS PLATE BREAK. ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2015-00047 FOLLOW UP 1: SCREW 1, MDR 3025141-2015-00048 FOLLOW UP 1: SCREW 2, MDR 3025141-2015-00052 FOLLOW UP 1: SCREW 6, MDR 3025141-2015-00053 FOLLOW UP 1: SCREW 7.

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF AN OLECRANON PLATE, THE PLATE BROKE. THE PLATE WAS EXPLANTED; HOWEVER, ONE OF THE SCREW COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176033 11 HOLE LOCKING OLECRANON PLATE PLATE, FIXATION, BONE HRS ACUMED LLC PL-LEO11 324260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention