BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5 MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 35 MM

    MDR report key: 18475035 · Received January 9, 2024

    Report

    Report Number
    3006460162-2024-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 8, 2024
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HWC
    UDI-DI
    00084113211093
    PMA / PMN Number
    NANA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PCTE 6 YEARS, PC, OTT DEROTADORA VARIZANTE RIGHT PROXIMAL FEMUR + OTT VARIZANTE DEROTADORA LEFT PROXIMAL FEMUR (DR (B)(6) REPOSCICIONA 1 CORTICAL SCREW 16 MM SINCE TO THE BROCAR WITHOUT COMPRESSION GUIDE THIS ONE WENT TO POSTERIOR, 2 NEEDLE GUIDE 2. 0 IN PROXIMAL FEMUR SINCE CHISEL ENTERS IN 150° APPROX AND GUIDE IN PROXIMAL END IS BENT WHEN REMOVING CHISEL COMES OUT WITH NEEDLE GUIDE AND IS REPLACED AND INSERTED PLATE IN BOTH FEMUR) IS ALSO PERFORMED TNT STRAIGHT (CRUDE REDUCTION) + TNT PSOAS + TNT ADDUCTORS LEFT HIP BUT LEFT HIP IS STILL DISLOCATED THEN DR MARTINEZ PERFORMS OTT PERIACETABULAR TYPE CHIARI FIXED WITH AUTOLOGOUS GRAFT OF PCTE LEFT HIP FIXED WITH NEEDLE K 1. 6 , UNDER RX IN AP AND LATERAL CONTINUOUS FEMORAL HEAD DOES NOT DISLOCATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554158 3.5 MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 35 MM 3.5 MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 35 MM HWC ORTHOPEDIATRICS, CORP 233811-J 00084113211093

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Hospitalization