BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS PEDILOC BONE SCREW

    MDR report key: 2941007 · Received January 30, 2013

    Report

    Report Number
    3006460162-2013-00003
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HRS
    PMA / PMN Number
    K083286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SCREW BROKEN FROM PLEO BONE PLATING PROCEDURE. NO OTHER INFO IS KNOWN. SALES REP IS ATTEMPTING TO OBTAIN ADDITIONAL INFO FROM SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40350 ORTHOPEDIATRICS PEDILOC BONE SCREW BONE SCREW HRS ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other