BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABY GORILLA/GORILLA PLATING SYSTEM

    MDR report key: 12914490 · Received December 2, 2021

    Report

    Report Number
    3008650117-2021-00134
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 2, 2021
    Report Date
    December 1, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    PMA / PMN Number
    K190365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HARDWARE REMOVAL SURGERY DUE TO IRRITATION. NO INDICATION OF DEVICE DEFICIENCY AND PATIENT'S BONE FUSED. DURING THE REMOVAL SURGERY THE SCREWS STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812707 BABY GORILLA/GORILLA PLATING SYSTEM BONE SCREW HWC PARAGON 28, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R| L