BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 4366205 · Received December 22, 2014

    Report

    Report Number
    3006460162-2014-00013
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HRS
    PMA / PMN Number
    K
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER DISCUSSION AND EMAIL BETWEEN ORTHOPEDIATRICS CHIEF MEDICAL OFFICER AND THE OPERATING SURGEON: THE DEVICE PERFORMED AS INTENDED AND COMPLETE HEALING OF OSTEOTOMY WAS ACCOMPLISHED. BROKEN NAIL WAS IDENTIFIED PRE-OPERATIVELY VIA X-RAY AND SURGEON ELECTED TO PROCEED WITH THE PLANNED REMOVAL SURGERY TO REMOVE ONLY THE PROXIMAL PORTION OF NAIL. REMAINING NAIL FRAGMENT IN PATIENT HAS NO ADVERSE EFFECT ON PATIENT OUTCOME.

    Description of Event or Problem · 1

    PREOPERATIVE X-RAY OF FEMUR PRIOR TO REGULAR SCHEDULED IM NAIL REMOVAL AFTER FRACTURE HEALING REVEALED THAT THE IM NAIL HAD FRACTURED AT ONE OF THE PROXIMAL TRANSVERSE SCREW HOLES. NORMAL HEALING OF FRACTURE HAD OCCURRED. ORIGINAL DOS:(B)(6) 2012. GOING TO REMOVE DUE TO FRACTURE BEING HEALED. REMOVAL DOS (B)(6) 2012 - DR. (B)(6). REMOVED TOP 30 MM OF THE NAIL - REMAINING NAIL IS STILL IN PATIENT. NAIL BROKE RIGHT AT THE TRANSFER SCREW HOLE. PATIENT: MALE WEIGHT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844116 NONE HRS ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK