BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDINAIL

    MDR report key: 4116775 · Received September 23, 2014

    Report

    Report Number
    4116775
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD A ROD PLACED ON THE LEFT SIDE AND THEN HAD A ROD PLACED IN THE RIGHT SIDE ON ABOUT TWO MONTHS LATER. THREE DAYS LATER, THE SURGEON TRIED TO REMOVE THE RODS BUT WAS UNSUCCESSFUL.LEFT SIDE - THE EXTRACTION DEVICE SHEARED OFF ON THE LEFT SIDE, NECESSITATING RETENTION OF THAT ROD, LEAVING THE THREADED PORTION ENGAGED IN THE TOP END OF THE ROD. THERE WAS NO OTHER TOOL AVAILABLE TO FACILITATE GRASPING THE ROD AND CONTINUING THE ATTEMPTED EXTRACTION. IT WAS DECIDED TO LEAVE IT IN PLACE. THE ROD WAS POUNDED BACK INTO PLACE SO THAT THE TIP WAS NOT PROMINENT ABOVE THE TROCHANTER. RIGHT SIDE - THE ROD BROKE THROUGH THE PROXIMAL SCREW HOLE RESULTING IN RETRIEVAL OF PORTION OF THE ROD ONLY.THE PATIENT'S MOM REPORTS THAT THE MANUFACTURER HAS NOW MADE A DESIGN CHANGE SINCE THIS EVENT. THE SURGEON FEELS THAT THE ISSUE WAS RELATED TO THE DESIGN. THIS SURGEON HAS USED THIS ROD DEVICE BEFORE AND HAS NEVER ENCOUNTERED THIS PROBLEM. THE PATIENT HAS BEEN LEFT WITH NEGATIVE IMPACTS DUE TO THIS DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591222 PEDINAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ORTHOPEDIATRICS, CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R| S NOT KNOWN.