BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM X 14.0MM LOCKING CORTICAL SCREW

    MDR report key: 2949135 · Received February 7, 2013

    Report

    Report Number
    3025141-2013-00024
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR # PART NUMBER 3025141-2013-00012; 70-0288, 3025141-2013-00013; PL-CL8LL, 3025141-2013-00014; CO-3160, 3025141-2013-00015; CO-3160, 3025141-2013-00016; CO-3160, 3025141-2013-00017; CO-3160, 3025141-2013-00018; CO-3160, 3025141-2013-00019; CO-3160, 3025141-2013-00020; CO-3160, 3025141-2013-00021; CO-3160, 3025141-2013-00022; CO-3140, 3025141-2013-00023; COL-3140, 3025141-2013-00025; COL-3140, 3025141-2013-00026; COL-3140.

    Description of Event or Problem · 1

    IN FIRST SURGERY, PATIENT UNDERWENT ORIF OPERATION FOR CLAVICLE FRACTURE, AT WHICH TIME A 70-0288 MIDSHAFT PLATE AND 6 3.5MM CORTICAL SCREWS WERE IMPLANTED. ONE OF THE SCREWS SUBSEQUENTLY BROKE, NECESSITATING A SECOND SURGERY. THE PLATE AND THE SCREWS WERE REPLACED WITH A PL-CL8LL AND 3 NON-LOCKING AND 3 LOCKING 3.5MM CORTICAL SCREWS. AFTER THE SECOND SURGERY, A LOCKING SCREW BROKE. A THIRD OPERATION WAS PERFORMED AND THE HARDWARE WAS REPLACED WITH A NEW PLATE AND NEW SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52706 3.5MM X 14.0MM LOCKING CORTICAL SCREW CONGRUENT BONE PLATE SYSTEM HRS ACUMED LLC COL-3140 255657

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention