BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORILLA PLATING SYSTEM

    MDR report key: 11839484 · Received May 18, 2021

    Report

    Report Number
    3008650117-2021-00091
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 18, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HRS
    PMA / PMN Number
    K190365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EVALUATION OF THE PRODUCT CONFIRMS THE FAILURE MODE OF THE PRODUCT BEING MISLABELED. THE IMPLANT WAS NOT USED AS IT WAS A REPLENISHMENT ORDER WHEN THE COMPLAINT INITIATOR NOTICED THE PROBLEM. HOWEVER, THIS MALFUNCTION IS RELATED TO A VIOLATION OF FDA REGULATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS NOT USED HOWEVER, THIS MALFUNCTION IS RELATED TO A VIOLATION OF FDA REGULATION. 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

    MISLABELING OF PRODUCT ON TEMPORARY PACKAGING. PART P53-203-R009 WAS LABELLED AS P53-102-L003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742579 GORILLA PLATING SYSTEM FIBULAR PLATE, CLUSTER, 9-HOLE, ANATOMICAL, RIGHT HRS PARAGON 28, INC. P53-203-R009 CP2103184

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR