BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ORTHOPEDIATRICS SCREW

    MDR report key: 9742973 · Received February 23, 2020

    Report

    Report Number
    3006460162-2019-00044
    Event Type
    Malfunction
    Date Received
    February 23, 2020
    Date of Event
    July 5, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HWC
    PMA / PMN Number
    K083726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: ITEM: 10-1500-054, IM FEMORAL NAIL, 10MM X 36CM, RIGHT, LOT: 7840301; ITEM: UNKNOWN, UNKNOWN ORTHOPEDIATRICS SCREW, LOT: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3006460162-2019-00043. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLANNED REMOVAL OF A INTERMEDULLARY NAIL, TWO SCREWS WERE DISCOVERED TO BE FRACTURED. OSTEOTOMY WAS HEALED AND THE FRACTURED SCREWS REMAINED IN THE PATIENT. A DELAY GREAT THAN THIRTY MINUTES WAS NOTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206353 UNKNOWN ORTHOPEDIATRICS SCREW SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1