BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM

    MDR report key: 25184466 · Received May 15, 2026

    Report

    Report Number
    3006460162-2026-00024
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ORTHOPEDIATRICS
    Product Code
    NKB
    UDI-DI
    00841132100325
    PMA / PMN Number
    K150600
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2026, ORTHOPEDIATRICS CORP. RECEIVED A COMPLAINT INVOLVING A 6.0 X 40 MM PEDICLE SCREW (P/N 00-1300-0640, LOT 246588-M) USED DURING A SCOLIOSIS PROCEDURE AT (B)(6) HOSPITAL. THE PEDICLE SCREW SHAFT FRACTURED POST OP. THE SURGEON REPORTED THAT THE TULIP AND A PORTION OF THE SHAFT WERE RETRIEVED; HOWEVER, A PORTION OF THE FRACTURED DEVICE REMAINED IN THE PATIENT. THE EVENT REQUIRED A REVISION PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110089 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM NKB ORTHOPEDIATRICS 00-1300-0640 246588-M 00841132100325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other