BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTEX SEMICONSTRAINED SCREW 4.0X16MM

    MDR report key: 5112493 · Received September 29, 2015

    Report

    Report Number
    3005673311-2015-00147
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    March 28, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    KWQ
    PMA / PMN Number
    K100243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RING HAS BEEN VISUALLY ANALYSED. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO MAKE AN ASSUMPTION ABOUT THE CAUSE AS TO WHY THE RINGS FELL OUT OF THE SCREWS. THE MOST LIKELY ROOT CAUSE OF THE FAILURE IS DESIGN. THE IFU (INFORMATION FOR USE) DOES NOT STATE THAT THE SCREWS MUST BE REMOVED IF THE RING FALLS OUT. CORRECTIVE/PREVENTIVE ACTIONS: IS NECESSARY AND HAS BEEN INITIATED.

    Description of Event or Problem · 1

    DURING SURGERY, TWO SAFETY RINGS DISASSEMBLED FROM THE QUINTEX SCREWS. THE SCREWS WERE LEFT IN THE PATIENT; ONLY ONE SAFETY RING COULD BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642741 QUINTEX SEMICONSTRAINED SCREW 4.0X16MM BONE SCREW KWQ AESCULAP IMPLANT SYSTEMS SC503T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other