BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE LOCKING PEDIATRIC OSTEOTOMY PLATE SYSTEM (LOLLIPOP)

    MDR report key: 15510780 · Received September 30, 2022

    Report

    Report Number
    3000327445-2022-00004
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Report Date
    September 16, 2022
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    KTT
    UDI-DI
    07540194006691
    PMA / PMN Number
    K170704
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON INDICATED NO ABNORMAL SITUATION HAPPEN DURING SURGERY AND HE HAD NO PROBLEM INSERTING THE SCREW CONNECTOR OF THE BLADE-PLATE ASSEMBLY.

    Description of Event or Problem · 0

    INFANT BLADE AND PLATE IMPLANTED THREE WEEKS AGO, DETACHED IN THE PATIENT. THE CONNECTOR THAT FIXED THE BLADE AND PLATE GOT LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827854 THE LOCKING PEDIATRIC OSTEOTOMY PLATE SYSTEM (LOLLIPOP) M3 CONNECTOR FOR INFANT KTT PEGA MEDICAL INC POP-M3I B151-01 07540194006691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other