MAUDE Adverse Event Report: ORTHOFIX CETRA; ANTERIOR CERVICAL PLATE

Model Number	19-0238
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Headache (1880)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that an unknown system was originally implanted at c3/4 in (b)(6) 2019.A revision was performed to extend the fusion to c4/5 in (b)(6) 2022 at that time a cetra 2 level plate was implanted at c3/4 - c4/5.On (b)(6) 2023 the patient presented in er due to headaches.X-rays were taken and it was found that the locking mechanism on the cetra plate had disengaged and one of the screws had migrated distal to the plate.The patient was taken to or where the cetra plate, locking mechanism and 5 of the screws were removed.The caudal screw was left in the patient.A subsequent surgery by ent to remove the remaining screw is scheduled for (b)(6) 2023.

• Brand Name: CETRA
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: ehab esmai ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 17166324
• Report Number: 2183449-2023-00003
• Device Sequence Number: 5386244
• Product Code: KWQ
• UDI-Device Identifier: 18257200120413
• UDI-Public: 18257200120413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/20/2023

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: Lay User/Patient
• Device Model Number: 19-0238
• Device Catalogue Number: 19-0238
• Device Lot Number: E27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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: 63 YR
• Patient Sex: Male