BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS PROXIMAL FEMUR PLATE SYSTEM

    MDR report key: 3856171 · Received April 25, 2014

    Report

    Report Number
    3006460162-2014-00004
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HWC
    PMA / PMN Number
    K111086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BONE SCREWS BENT INTRA-OPERATIVELY. AFTER PLATE WAS FIXED, SURGEON TRIED TO REDUCT IT AND NOTICED ON X-RAY THAT SCREW WAS BENT. EXTENDED SURGERY BY 30 MINS BECAUSE OF THE TIME TAKEN TO REPLACE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252331 ORTHOPEDIATRICS PROXIMAL FEMUR PLATE SYSTEM BONE SCREW HWC ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other