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

Model Number	19-0236
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient with new herniated nucleus pulpous (hnp) at c6/7 (below fusion) after a fall-- with cord compression.
Additional Manufacturer Narrative
Product was not returned for investigation.If the product or additional information is received an investigation will be performed at that time.

• 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: 50015873
• Report Number: 2183449-2026-00038
• Device Sequence Number: 18525266
• Product Code: KWQ
• UDI-Device Identifier: 18257200120406
• UDI-Public: 18257200120406
• 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: 2018
• Device Explanted Year: 2019
• 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: 19-0236
• 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: Not provided
• 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: Other
• Patient Age: 81 YR
• Patient Sex: Female