BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCLAGE WIRES

    MDR report key: 382180 · Received March 13, 2002

    Report

    Report Number
    382180
    Event Type
    Injury
    Date Received
    March 13, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 12, 2002
    Manufacturer
    UNK
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF PATELLAR FRACTURE S/P OPEN REDUCTION AND INTERNAL FIXATION WITH CERCLAGE WIRES. ONE OF THE PIECES HAD BECOME LOOSE AND THE PT REPORTED PAIN. HX S/P PATELLA FRACTURE ORIF AND REDO SEVERAL MONTHS LATER AT ANOTHER FACILITY 2 YRS AGO. FRACTURE HEALED THEREFORE UNDERWENT REMOVAL IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERCLAGE WIRES WIRES FOR OPEN REDUCTION FRACTURE JDQ UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization