BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING CORTICAL SCREW

    MDR report key: 10515284 · Received September 10, 2020

    Report

    Report Number
    3006460162-2020-00101
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 10, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HWC
    PMA / PMN Number
    K100240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF A TIBIA PLATE WITH LOCKING SCREWS IN THE DIAL CLUSTER. ONE OF THE LOCKING SCREWS BROKE UPON REMOVAL. IT SNAPPED AT THE JUNCTION OF THE SCREW HEAD AND THREADED SHAFT. A DELAY IN SURGERY OF GREATER THEN 30-MINUTES WAS REPORTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978291 LOCKING CORTICAL SCREW BONE SCREW HWC ORTHOPEDIATRICS, CORP 00-0903-2642 178023-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other