BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORILLA PLATING SYSTEM

    MDR report key: 10933722 · Received December 2, 2020

    Report

    Report Number
    3008650117-2020-00213
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    March 1, 2017
    Report Date
    December 1, 2020
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HRS
    PMA / PMN Number
    K190365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND MET ALL MATERIAL SPECIFICATIONS WITH NO DEVIATION 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE THAT UTILIZED PARAGON 28 GORILLA PLATING SYSTEM. THE MTP PLATE BROKE ACROSS THE GUIDE HOLES AT 6 WEEKS POST OPERATIVELY. IT WAS REPORTED THAT A COMPRESSION SCREW WAS NOT USED IN THE CASE. THE IMPLANTATION DATE WAS SAID TO BE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400198 GORILLA PLATING SYSTEM BONE PLATE HRS PARAGON 28, INC. P53-103-R051 JP0139

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention