MAUDE Adverse Event Report: ORTHOFIX, LLC FIREBIRD NXG; ST SCREW

Model Number	36-2001
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product return was requested.The set screw (pn: 36-2001 ln: unk) was not returned for investigation, therefore the reported complaint cannot be confirmed.Should additional information be received or the device returns for investigation, the complaint will be reopened and then evaluated.
Event or Problem Description
It was reported that a patient went to a follow up visit 3-4 weeks after surgery and a set screw was found to be loose on post op imaging at l2-l3 level.The patient required a revision surgery that extended up one level from previous hardware.Patient did not report any pain.Further details were requested.No further details have been provided.
Additional Manufacturer Narrative
Product has not returned for investigation.Additional information has been requested along with the return of the device.
Event or Problem Description
It was reported that a patient went to a follow up visit 3-4 weeks after surgery and a set screw was found to be loose on post op imaging at l2-l3 level.The patient required a revision surgery that extended up one level from previous hardware.Patient did not report any pain.No further details have been provided at this time.Part number is unknown at this time.Additional information and return of the device has been requested.

• Brand Name: FIREBIRD NXG
• Common Device Name: ST SCREW
• Manufacturer (Section D): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 21327513
• Report Number: 2183449-2025-00003
• Device Sequence Number: 12729149
• Product Code: NKB
• UDI-Device Identifier: 18257200084487
• UDI-Public: 18257200084487
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K180179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/26/2025
• 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: 58 YR
• Patient Sex: Female