BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW, LARGE

    MDR report key: 11976273 · Received June 10, 2021

    Report

    Report Number
    3006460162-2021-00010
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS INSTRUMENTED ON FROM T10-L4 ON (B)(6) 2021. AFTER SURGERY, THE PATIENT REPORTED A "POP" IN HIS BACK WHILE BENDING OVER. UPON ASSESSMENT, IT WAS DISCOVERED THAT THE SET SCREW AT LEFT T10 FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877248 SET SCREW, LARGE PEDICLE SCREW NKB ORTHOPEDIATRICS, CORP 00-1003-4001

    Patients

    Seq Age Sex Outcome Treatment
    1