BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IM FEMORAL NAIL, 9 MM X 34CM, LEFT

    MDR report key: 11938069 · Received June 4, 2021

    Report

    Report Number
    3006460162-2021-00007
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    March 9, 2020
    Report Date
    June 2, 2021
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NAIL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833563 IM FEMORAL NAIL, 9 MM X 34CM, LEFT IM FEMORAL NAIL HSB ORTHOPEDIATRICS, CORP 10-1500-094 176675-N

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR