MAUDE Adverse Event Report: ORTHOFIX, LLC FIREBIRD SI FUSION; 11MM X 35MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE

Model Number	18-1035SP
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts have been made to gather additional details with no results.Should new information become available a follow-up report will be submitted.
Event or Problem Description
As per the reporter an expired 18-1035sp was implanted in the patient.No further information was received.

• Brand Name: FIREBIRD SI FUSION
• Common Device Name: 11MM X 35MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
• 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: 24956899
• Report Number: 2183449-2026-00014
• Device Sequence Number: 13269352
• Product Code: OUR
• UDI-Device Identifier: 18257200140107
• UDI-Public: 18257200140107
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: Health Professional
• Device Expiration Date: 09/24/2025
• Device Model Number: 18-1035SP
• Device Lot Number: 013
• 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: 03/25/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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 Sex: Unknown