BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM

    MDR report key: 10693246 · Received October 16, 2020

    Report

    Report Number
    3000327445-2020-00006
    Event Type
    Injury
    Date Received
    October 16, 2020
    Report Date
    October 16, 2020
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    KTT
    UDI-DI
    07540194005854
    PMA / PMN Number
    K170704
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NONUNION OF THE BONE OCCURRED MOST LIKELY DUE TO THE OSTEOPENIC CONDITION OF THE PATIENT'S BONE. IT APPEARS THAT THE CYCLIC LOADING AFTER THE NONUNION RESULTED IN THE UNSCREWING OF THE CONNECTOR AND THE FAILURE OF THE MOST DISTAL CORTICAL SCREW. BOTH CONSEQUENCES ARE PREDICTABLE CONSIDERING THE LONG PERIOD OF IMPLANTATION WITH THE NONUNION (MORE THAN 2 YEARS).

    Description of Event or Problem · 1

    A COMPRESSION SCREWS ATTACHING THE PLATE TO THE BONE BROKE BEING IMPLANTED IN AN INFANT PATIENT. INITIAL SURGERY: (B)(6) 2018 (B)(6)OF AGE). 2 YEARS AND 3 MONTHS IMPLANTATION BEFORE DETECTION OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155017 THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM COMPRESSION SCREW, Ø2.7X32MM KTT PEGA MEDICAL INC. COMPRESSION SCREW, Ø2.7X32MM 160714-020 07540194005854

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention