BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSTER SCREW SYSTEM

    MDR report key: 11881397 · Received May 25, 2021

    Report

    Report Number
    3008650117-2021-00094
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 24, 2021
    Report Date
    May 25, 2021
    Manufacturer
    PARAGON 28, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE PRODUCT VERIFIES THE DRILL TIP IS VISIBLY BROKEN. DHR REVIEW OF P99-190-TT08 LOT TC31017 WAS CONDUCTED, AND INSPECTION WAS SIGNED ON 3.22.2019. 144 PARTS WERE RECEIVED AND ACCEPTED. NO NCR IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    ISSUE REPORTED WITH THE SCREW DRIVER ATTACHMENT, CANNULATED, MODIFIED TX-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778558 MONSTER SCREW SYSTEM SCREW DRIVER ATTACHMENT, CANNULATED, MODIFIED TX-8 HWC PARAGON 28, INC P99-190-TT08 TC31017

    Patients

    Seq Age Sex Outcome Treatment
    1