BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABY GORILLA®/GORILLA® PLATING SYSTEM

    MDR report key: 12981623 · Received December 11, 2021

    Report

    Report Number
    3008650117-2021-00136
    Event Type
    Injury
    Date Received
    December 11, 2021
    Date of Event
    November 11, 2021
    Report Date
    December 20, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    PMA / PMN Number
    K190365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION OF THE PROVIDED RADIOGRAPHIC IMAGES COMPLETED; PLATE BREAKAGE IS OBSERVED AT THE LEVEL OF THE INTERFACE BETWEEN THE CAGE AND THE TALUS. SCREW BREAKAGE IS OBSERVED IN THE TWO PROXIMAL TIBIA SCREWS, WITH THE REMAINING SCREW INTACT IN THE TIBIA. USER ERROR IS INDICATED BECAUSE A CROSSING SCREW WAS NOT USED, USE OF A CROSSING SCREW IS REQUIRED FOR THIS PROCEDURE. HOWEVER, PER CLINICAL, THIS WAS A LIMB SALVAGE CASE. USE OF A CAGE IN THIS CASE DID NOT ALLOW THE SURGEON TO USE A CROSSING SCREW.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION OF THE PROVIDED RADIOGRAPHIC IMAGES COMPLETED; PLATE BREAKAGE IS OBSERVED AT THE LEVEL OF THE INTERFACE BETWEEN THE CAGE AND THE TALUS. SCREW BREAKAGE IS OBSERVED IN THE TWO PROXIMAL TIBIA SCREWS, WITH THE REMAINING SCREW INTACT IN THE TIBIA. USER ERROR IS INDICATED BECAUSE A CROSSING SCREW WAS NOT USED. USE OF A CROSSING SCREW IS REQUIRED FOR THIS PROCEDURE.

    Description of Event or Problem · 0

    REPORT OF A POST-OPERATIVE BREAK OF A LATERAL TTC PLATE AND 2 SILVERBACK LOCKING PLATE SCREWS. A REVISION SURGERY WAS COMPLETED TO REMOVE ALL THE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879553 BABY GORILLA®/GORILLA® PLATING SYSTEM SILVERBACK LOCKING PLATE SCREW, 4.5 HWC PARAGON 28, INC. P50-553-45XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention