BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD NXG POCT

    MDR report key: 21326995 · Received February 6, 2025

    Report

    Report Number
    2183449-2025-00005
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 13, 2025
    Report Date
    April 29, 2025
    Manufacturer
    ORTHOFIX US LLC
    Product Code
    NKB
    UDI-DI
    18257200084487
    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 DID NOT RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE SET SCREWS (PN: 36-2001 LN: UNK) WERE NOT RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE FIREBIRD NXG SET SCREWS BACKED OUT ON AN L2-PELVIS JANUS FENESTRATED CASE (LEGACY ORTHOFIX), AND WAS DISCOVERED DURING A ROUTINE FOLLOW UP EXAM WITH IMAGING. TWO RADIOGRAPHS WERE PROVIDED AND CONFIRMED 2 OF THE SET SCREWS HAD BACKED OUT FROM THE CONSTRUCT. IT SHOULD BE NOTED THAT THE PRIMARY SURGERY WAS PERFORMED USING 5.5X140MM MARINER MIS RODS (MM1-155140). THIS WAS AN OFF-LABEL USE - USAGE OF A LEGACY SEASPINE PRODUCT (MARINER MIS ROD) WITH AFOREMENTIONED LEGACY ORTHOFIX PRODUCTS. CEMENT WAS ALSO USED WITH THE FENESTRATED SCREWS, WHICH IS NOT INDICATED FOR USE IN THE US. THE REVISION SURGERY WAS PERFORMED USING 5.5X160MM ORTHOFIX STRAIGHT RODS (53-2160). THREE TORQUE HANDLES WERE RETURNED BY THE REP AND ONE OF THE HANDLES WAS FOUND TO BE SLIGHTLY UNDER SPEC. HOWEVER, IT IS NOT KNOWN WHICH OF THE THREE HANDLES WAS ACTUALLY USED IN THIS CASE. THE OFF-LABEL USE, SHORTER INITIAL ROD, AND THE TORQUE HANDLE BELOW SPEC COULD ALL BE CONTRIBUTING FACTORS TO THE POST-OP FAILURE OF THE CONSTRUCT. AN HHE (HHE-25-009) WAS INITIATED TO FURTHER EVALUATE THIS CASE AND ASSOCIATED RISKS. WITHOUT A LOT NUMBER, A REVIEW OF THE DHR AND NCMR DATABASE CANNOT BE COMPLETED.

    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.

    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
    622708 FIREBIRD NXG POCT SET SCREW NKB ORTHOFIX US LLC 36-2001 18257200084487

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other