BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEDILOC CONTOUR FEMUR PLATE

    MDR report key: 2660774 · Received July 12, 2012

    Report

    Report Number
    3006460162-2012-00004
    Event Type
    Other
    Date Received
    July 12, 2012
    Date of Event
    December 1, 2011
    Report Date
    June 12, 2012
    Manufacturer
    ORTHOPEDIATRICS CORP.
    Product Code
    HRS
    Removal / Correction Number
    3006460162-06-14-2012-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLIER CORRECTIVE ACTION HAS BEEN ISSUED TO CONTRACT MFR RESPONSIBLE FOR PRODUCTION AND LABELING OF DEVICES IN THIS LOT. ENTIRE LOT HAS BEEN RECALLED. RECALL #3006460162-06-14-2012-001-R. TOTAL OF (15) DEVICES. ELEVEN OF FIFTEEN DEVICES ARE NOT ACCOUNTED FOR, WITH TEN OF ELEVEN DEVICES IN QUARANTINE. ONE DEVICE IS KNOWN TO HAVE BEEN IMPLANTED. MFR'S MEDICAL DIRECTOR, AN ORTHOPEDIC SURGEON, IS INITIATING CONTACT WITH IMPLANTING SURGEON TO DETERMINE IF ANY ADVERSE EVENTS ARE ATTRIBUTABLE TO THE MISLABELING. FOUR, UNACCOUNTED DEVICES ARE BEING INVESTIGATED PER THE RECALL PLAN.

    Description of Event or Problem · 1

    SALES REP DISCOVERED RECEIPT OF MISLABELED AND MIS-ETCHED BONE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDILOC CONTOUR FEMUR PLATE BONE PLATE HRS ORTHOPEDIATRICS CORP. 7736703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other