MAUDE Adverse Event Report: Orthofix, LLC CETRA; 1-LEVEL PLATE ASSEMBLY, 20MM

Model Number	19-0120
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported several hours postoperatively the patient experienced a tense neck and difficulty breathing.Patient was intubated successfully and emergently taken to the operating room for incision and drainage of a postoperative neck hematoma.After the second surgery, she did well without any further complications.
Additional Manufacturer Narrative
Product did not return for investigation.If the product returns or new information becomes available an investigation will be performed at that time.

• Brand Name: CETRA
• Common Device Name: 1-LEVEL PLATE ASSEMBLY, 20MM
• 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: 50015857
• Report Number: 2183449-2026-00037
• Device Sequence Number: 21204596
• Product Code: KWQ
• UDI-Device Identifier: 18257200120291
• UDI-Public: 18257200120291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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 Model Number: 19-0120
• 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: 06/26/2026
• Initial Report FDA Received Date: 07/27/2026
• 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 Age: 63 YR
• Patient Sex: Female