BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWER ORTHOPEDICS CORPORATION

    MDR report key: 11509368 · Received March 17, 2021

    Report

    Report Number
    3009996260-2021-00003
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 17, 2021
    Manufacturer
    FLOWER ORTHOPEDICS
    Product Code
    HWC
    UDI-DI
    00840118110686
    PMA / PMN Number
    K132248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT INCLUDED A SCREW WHICH COLLIDED WITH IMPLANTED SCREW DURING INSERTION AND FRACTURED UPON IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403768 FLOWER ORTHOPEDICS CORPORATION CANNULATED SCREW, PARTIALLY THREADED, D: 4.0MM HWC FLOWER ORTHOPEDICS CNP 432 2015001033 00840118110686

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other