BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIABLE ANGLE LOCKING SCREW

    MDR report key: 15501137 · Received September 29, 2022

    Report

    Report Number
    3009996260-2022-00004
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 2, 2022
    Report Date
    September 28, 2022
    Manufacturer
    FLOWER ORTHOPEDICS DBA CONVENTUS FLOWER ORTHOPEDIC
    Product Code
    HWC
    UDI-DI
    00840118100830
    PMA / PMN Number
    K123562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A COMPLAINT WAS INITIATED ON (B)(6) 2022 FOR AN EXPIRED IMPLANT (FRP 318 000 SCREW) THAT WAS IMPLANTED (EXPIRY DATE 2022-04).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926560 VARIABLE ANGLE LOCKING SCREW SCREW, FIXATION, BONE HWC FLOWER ORTHOPEDICS DBA CONVENTUS FLOWER ORTHOPEDIC FRP 318 2015000963 00840118100830

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization