MAUDE Adverse Event Report: Orthofix Srl CHIMAERA HFS LAG SCREW FIXED L95MM STERILE

Model Number	CHIMAERA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction

• Brand Name: CHIMAERA HFS LAG SCREW FIXED L95MM STERILE
• Common Device Name: CHIMAERA HFS LAG SCREW FIXED L95MM STERILE
• Manufacturer (Section D): Orthofix Srl; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): Orthofix Srl; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 50550450
• Report Number: 9680825-2026-00050
• Device Sequence Number: 13408796
• Product Code: HSB
• UDI-Device Identifier: 18054242514923
• UDI-Public: 18054242514923
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K161466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: Health Professional
• Device Model Number: CHIMAERA
• Device Catalogue Number: 99-T93695
• Device Lot Number: B5548822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 171 LB