BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWER ORTHOPEDICS CORPORATION

    MDR report key: 11589217 · Received March 30, 2021

    Report

    Report Number
    3009996260-2021-00005
    Event Type
    Injury
    Date Received
    March 30, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 29, 2021
    Manufacturer
    FLOWER ORTHOPEDICS
    Product Code
    HWC
    UDI-DI
    00840118104593
    PMA / PMN Number
    K123562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM X 26MM LOCKING SCREW (FLP 326) SCREW BROKE AFTER NEARLY 9 MONTHS OF IMPLANTATION. THIS EVENT IS ASSOCIATED WITH THE SAME PATIENT AND SURGICAL PROCEDURE AS DESCRIBED IN MDR 3009996260-2021-00003 AND 3009996260-2021-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485794 FLOWER ORTHOPEDICS CORPORATION VARIABLE ANGLE LOCKING SCREW, LOW PROFILE, D:3.0MM X L:26MM HWC FLOWER ORTHOPEDICS FLP 326 2014000322 00840118104593

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R