MAUDE Adverse Event Report: ORTHOFIX, LLC CETRA; 2-LEVEL PLATE ASSEMBLY, 36MM

Model Number	19-0236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information and device return has been requested.If the device returns and investigation will be performed.
Event or Problem Description
It was reported that a patient received a 36mm cetra plate with two ti cages in (b)(6) 2025.At a follow up visit the physician noticed two inferior screws had backed out.The patient subsequently underwent a revision of the acdf on (b)(6) 2025.During the revision it was observed the locking plate has broken off of the plate.The physician removed the entire consrtuct and revised completely.

• Brand Name: CETRA
• Common Device Name: 2-LEVEL PLATE ASSEMBLY, 36MM
• 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: 23707312
• Report Number: 2183449-2025-00034
• Device Sequence Number: 10649561
• Product Code: KWQ
• UDI-Device Identifier: 18257200120406
• UDI-Public: 18257200120406
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K162638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: Health Professional
• Device Model Number: 19-0236
• 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: 11/12/2025
• Initial Report FDA Received Date: 12/03/2025
• 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: Required Intervention
• Patient Sex: Unknown