MAUDE Adverse Event Report: ORTHOFIX CETRA; ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	19-0354
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved was not returned for evaluation.
Event or Problem Description
Information provided states that patient had acdf (anterior cervical discectomy fusion) at levels c4-c7 in (b)(6) 2023.Patient returned for 6 week follow and images showed the interior locking mechanism of the cetra plate had failed.The device was explanted on (b)(6) 2023.

• Brand Name: CETRA
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 18531998
• Report Number: 2183449-2024-00001
• Device Sequence Number: 12431337
• Product Code: KWQ
• UDI-Device Identifier: 18257200120536
• UDI-Public: 18257200120536
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2024

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: Lay User/Patient
• Device Catalogue Number: 19-0354
• Device Lot Number: E26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: 70 YR
• Patient Sex: Female