BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD NXG POCT

    MDR report key: 21293365 · Received February 3, 2025

    Report

    Report Number
    2183449-2025-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 11, 2025
    Manufacturer
    ORTHOFIX US LLC
    Product Code
    NKB
    UDI-DI
    18257200110254
    PMA / PMN Number
    K180179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE DIDNOT RETURNED FOR INVESTIGATION. UPON FURTHER DISCUSSION WITH THE DISTRIBUTOR, IT WAS REPORTED THAT THE 36-2101 TOP LOADING BODY WAS NOT EXPLANTED FROM THE PATIENT, NOR INVOLVED IN A MALFUNCTION OR ADVERSE EVENT. THIS FOLLOW UP REPORT IS TO CANCEL THIS SUBMISSION. PLEASE REFERENCE MFR REPORT NUMBER 2183449-2025-00001 FOR THE SUBJECT DEVICE AND REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE DIDNOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WENT TO A ROUTINE FOLLOW UP VISIT AFTER A DECOMPRESSION AND FUSION WITH THE USE OF FENESTERATED SCREWS THAT WERE IMPLANTED (B)(6) 2024. THE FOLLOW UP EXAM CONSISTED OF IMAGING THAT SHOWED SET SCREW BACKED OUT ON AN L2 -PELVIS JANUSUS FENESTRATED CASE. THE PATIENT REQUIRED A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2025. NO SYMPTOMS WERE REPORTED BY PATIENT. UPON FURTHER DISCUSSION WITH THE DISTRIBUTOR, IT WAS REPORTED THAT THE 36-2101 TOP LOADING BODY WAS NOT EXPLANTED FROM THE PATIENT, NOR INVOLVED IN A MALFUNCTION OR ADVERSE EVENT. THIS FOLLOW UP REPORT IS TO CANCEL THIS SUBMISSION. PLEASE REFERENCE MFR REPORT NUMBER 2183449-2025-00001 FOR THE SUBJECT DEVICE AND REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WENT TO A ROUTINE FOLLOW UP VISIT AFTER A DECOMPRESSION AND FUSION WITH THE USE OF FENESTERATED SCREWS THAT WERE IMPLANTED (B)(6) 2024. THE FOLLOW UP EXAM CONSISTED OF IMAGING THAT SHOWED SET SCREW BACKED OUT ON AN L2 -PELVIS JANUSUS FENESTRATED CASE. THE PATIENT REQUIRED A REVISION SURGERY THAT TOOK PLACE ON (B)(6)2025. NO SYMPTOMS WERE REPORTED BY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190570 FIREBIRD NXG POCT TOP LOADING BODY NKB ORTHOFIX US LLC 36-2101 18257200110254

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other