BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY GORILLA/GORILLA PLATING SYSTEM

    MDR report key: 11749899 · Received April 29, 2021

    Report

    Report Number
    3008650117-2021-00086
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 29, 2021
    Manufacturer
    PARAGON 28, INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL INFORMATION RECEIVED. ATTEMPTING TO HAVE PIECE NOT IN PATIENT RETURNED FOR INSPECTION. FURTHER INFORMATION IS EXPECTED TO BE OBTAINED; A SUBSEQUENTIAL REPORT WILL BE FILED ACCORDINGLY. 5.17.2021 FINAL REPORT UPDATE. LOT NUMBER PROVIDED BY INITIATOR IS NOT VALID FOR ANY PARAGON 28 PRODUCT. LOT OR2009006 REMOVED FROM LOT AREA OF 3500A. PART STILL IMPLANTED IN PATIENT. NO FURTHER INFORMATION EXPECTED AT THIS TIME; IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    COMPLAINT INITIATOR STATED, "THE SURGEONS PERFORMED AN OPERATION AND A DRILL BROKE INSIDE." X-RAY PROVIDED DISPLAYING THE BROKEN DRILL PIECE IN PATIENT.

    Additional Manufacturer Narrative · 1

    INITIAL INFORMATION RECEIVED. ATTEMPTING TO HAVE PIECE NOT IN PATIENT RETURNED FOR INSPECTION. FURTHER INFORMATION IS EXPECTED TO BE OBTAINED; A SUBSEQUENTIAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    COMPLAINT INITIATOR STATED, "THE SURGEONS PERFORMED AN OPERATION AND A DRILL BROKE INSIDE." X-RAY PROVIDED DISPLAYING THE BROKEN DRILL PIECE IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647184 BABY GORILLA/GORILLA PLATING SYSTEM DRILL, 2.8 X 160MM, SOLID, MEASURING, LONG, AO HTW PARAGON 28, INC P99-100-2816 OR2009006

    Patients

    Seq Age Sex Outcome Treatment
    1