BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW TRAUMA

    MDR report key: 17526416 · Received August 12, 2023

    Report

    Report Number
    MW5133355
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    February 15, 2022
    Report Date
    February 22, 2022
    Manufacturer
    STRYKER INC.
    Product Code
    HWC
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, SURGEON REMOVED STRYKER SCREW(S). THERE WERE NO COMPLAINTS OR ADVERSE EVENTS COMMUNICATED RELATED TO THIS SCREW REMOVAL. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182530 SCREW TRAUMA SCREW, FIXATION, BONE HWC STRYKER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown