MAUDE Adverse Event Report: ORTHOFIX US LLC FIREBIRD NXG POCT; TOP LOADING BODY

Model Number	36-2101
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
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 device didnot returned for investigation.
Additional Manufacturer Narrative
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.
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.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.

• Brand Name: FIREBIRD NXG POCT
• Common Device Name: TOP LOADING BODY
• 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: 21293365
• Report Number: 2183449-2025-00002
• Device Sequence Number: 7775201
• Product Code: NKB
• UDI-Device Identifier: 18257200110254
• UDI-Public: 18257200110254
• 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): 02/11/2025

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: 36-2101
• 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: 02/11/2025
• 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