MAUDE Adverse Event Report: ORTHOFIX US LLC FIREBIRD NXG POCT; SET SCREW

Model Number	36-2001
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device did not returned for investigation.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: FIREBIRD NXG POCT
• Common Device Name: SET SCREW
• Manufacturer (Section D): ORTHOFIX US LLC; 3451 plano parkway; lewsiville TX
• Manufacturer (Section G): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 21293671
• Report Number: 2183449-2025-00001
• Device Sequence Number: 9244925
• Product Code: NKB
• UDI-Device Identifier: 18257200084487
• UDI-Public: 18257200084487
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 36-2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male