BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ORTHOPEDIATRICS LOCKING SCREW

    MDR report key: 9386709 · Received November 27, 2019

    Report

    Report Number
    3006460162-2019-00066
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 27, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HWC
    PMA / PMN Number
    K111086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT DEVICE: ITEM NUMBER: 00-0907-2104, 130 DEG X 3.5MM PLATE 4-HOLE, LOT NUMBER: M113323-G. PHOTO OF THE X-RAY WAS REVIEWED AND CONFIRMED THE REPORTED FAILURE. DEVICES WERE NOT RETURNED FOR ANALYSIS. A DHR REVIEW WAS CONDUCTED FOR 00-0907-2104 AND FOUND NO MANUFACTURING DEFECTS OR DESIGN ERRORS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2019-00065.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING THE PLACEMENT OF A LOCKING CANNULATED BLADE PLATE, THE PATIENT UNDERWENT A REVISION DUE TO A LOCKING SCREW BACKING OUT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175849 UNKNOWN ORTHOPEDIATRICS LOCKING SCREW SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention