MAUDE Adverse Event Report: ORTHOFIX US LLC CETRA; 1-LEVEL PLATE ASSEMBLY, 26MM

Model Number	19-0126
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product has not returned for investigation.
Event or Problem Description
It was reported that a female patient had acdf (b)(6) 2023.A planned revision acdf c6/7 was performed on the patient (b)(6) 2024.On (b)(6) 2024 the patient had a removal of the cetra plate due to it becoming loose from the (b)(6) 2024 surgery.It was reported that upon removal the c6 locking mechanism was sheered off.
Additional Manufacturer Narrative
The 1-level plate assembly (pn: 19-0126 ln: e19) was returned for investigation.The plate was returned with 3 screws.Attempts made to gather additional information and inquire about the 4th screw were unsuccessful.The edges of the locking plate that broke off are deformed, likely from contacting the head of the screws.The screw heads also show deformation.The locking tab likely failed because of ductile overload and ductile shear overload on the screw.The locking tab was likely subjected to overload by leaving the screws proud causing the locking tab to stress at fillet which is weaker cross section of the design.A review of the product dhr showed that all inspections met design specifications.A review of the ncmr databases did not reveal any nonconformances related to this investigation.
Event or Problem Description
It was reported that a female patient had acdf on (b)(6) 2023.A planned revision acdf c6/7 was performed on the patient on (b)(6) 2024.On (b)(6) 2024 the patient had a removal of the cetra plate due to it becoming loose from the (b)(6) 2024 surgery.It was reported that upon removal the c6 locking mechanism was sheered off.

• Brand Name: CETRA
• Common Device Name: 1-LEVEL PLATE ASSEMBLY, 26MM
• Manufacturer (Section D): ORTHOFIX US LLC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX US LLC; 3451 plano parkway; lewsiville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano parkway; lewisville, TX 75056
• MDR Report Key: 20570541
• Report Number: 2183449-2024-00021
• Device Sequence Number: 8555298
• Product Code: KWQ
• UDI-Device Identifier: 18257200120321
• UDI-Public: 18257200120321
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 19-0126
• Device Lot Number: E19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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: 69 YR
• Patient Sex: Female