BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABY GORILLA/GORILLA PLATING SYSTEM

    MDR report key: 11632606 · Received April 8, 2021

    Report

    Report Number
    3008650117-2021-00081
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 8, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    PMA / PMN Number
    K190365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IDENTIFYING INFORMATION, SUCH AS THE LOT NUMBER OF THE DEVICE WAS NOT REPORTED. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED BECAUSE THE LOT NUMBER WAS NOT REPORTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR THE MANUFACTURER REVIEW/INVESTIGATION BECAUSE IT WAS LEFT IN THE PATIENT. 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 PARAGON 28 3.5 X 18MM R3CON LOCKING PLATE SCREW BROKE POST OPERATIVELY. THE ORIGINAL SURGERY WAS ON (B)(6) 2020 AND A REVISION SURGERY WAS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE PART REMAINED IN THE PATIENT AND THE REASON FOR THE REVISION WAS DUE TO A NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532298 BABY GORILLA/GORILLA PLATING SYSTEM BONE SCREW HWC PARAGON 28, INC. P50-353-3518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention