BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM

    MDR report key: 23262170 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00002
    Event Type
    Injury
    Date Received
    October 9, 2025
    Report Date
    October 9, 2025
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    KTT
    PMA / PMN Number
    K170704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL REPRESENTATIVE REACHED OUT TO ORTHOGERIATRICS CANADA LOOKING FOR SOME ADVICE REGARDING A LOLLIPOP IMPLANT. IN PARTICULAR, A BLADE DETACHED FROM A PLATE INSIDE THE PATIENT SOMETIME AFTER BOTH WERE IMPLANTED. ON THE X-RAYS PROVIDED IT CAN BE SEEN THAT THE BLADE DISENGAGED FROM THE PLATE. FROM THE ANALYSIS DONE IT WAS CONCLUDED THAT THE REASON OF DISASSEMBLY OF THE PARTS WAS THE FACT THAT THE TOP LEFT CORNER OF THE BLADE'S BUTTRESS WAS NOT FULLY ENGAGED IN THE PLATE AT THE MOMENT OF THE INITIAL INSERTION SURGERY. THIS LED TO THE DISASSEMBLY OF THE PARTS. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2024-00002 ON MAY 2, 2024, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    THE HOSPITAL REPRESENTATIVE REACHED OUT TO PEGA MEDICAL LOOKING FOR SOME ADVICE REGARDING A LOLLIPOP IMPLANT. IN PARTICULAR, A BLADE DETACHED FROM A PLATE INSIDE THE PATIENT SOMETIME AFTER BOTH IMPLANT COMPONENTS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577707 THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM ADOLESCENT BLADE KTT PEGA MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention