BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORILLA/BABY GORILLA PLATING SYSTEM

    MDR report key: 10546591 · Received September 17, 2020

    Report

    Report Number
    3008650117-2020-00068
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 11, 2020
    Manufacturer
    PARAGON 28, INC
    Product Code
    HRS
    PMA / PMN Number
    K190365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION CORRECTED SECTION G5 (PMA/510(K) #: K190365).

    Additional Manufacturer Narrative · 1

    DEVICES ARE NOT EXPECTED TO BE RETURNED FOR THE MANUFACTURER REVIEW/INVESTIGATION. THE DEVICE MANUFACTURING AND INSPECTION RECORDS WERE NOT ANALYZED FOR THE IMPLANTS BECAUSE IDENTIFYING INFORMATION SUCH AS PART NUMBER, LOT NUMBER, OR UDI WERE NOT RETURNED. IN ADDITION, THE IMPLANTATION DATE WAS NOT PROVIDED. 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

    A PARAGON 28 LATERAL COLUMN FUSION GORILLA PLATE AND ASSOCIATED SCREWS WERE REMOVED FROM A PATIENT ON (B)(6) 2020. THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS NOT PROVIDED. HOWEVER, UPON REMOVAL OF THE IMPLANTS THE PATIENT'S TISSUE WAS FOUND TO BE GREY IN COLOR AT THE SITE WHERE THE PLATE WAS SITTING. THE SURGEON PROVIDED INFORMATION THAT THE PATIENT HAS A NICKEL ALLERGY AND HAS HAD A PREVIOUS HARDWARE REMOVAL OF AN UNIDENTIFIED COMPETITOR'S PRODUCT, WHICH THE SURGEON STATED MAY BE A CONTRIBUTING FACTOR TO THE TISSUE DISCOLORATION. AFTER THE REMOVAL OF PARAGON 28 LATERAL COLUMN FUSION PLATE AND ASSOCIATED SCREWS, AN UNIDENTIFIED COMPETITOR'S PRODUCT WAS USED TO FUSE THE HINDFOOT. THE PATIENT CONDITION IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015317 GORILLA/BABY GORILLA PLATING SYSTEM BONE PLATE SYSTEM HRS PARAGON 28, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention