MAUDE Adverse Event Report: ORTHOFIX, LLC CETRA; 4.0MM X 14MM PRIMARY SEMI-CONSTRAINED SELF DRILLING SCREW

Model Number	19-6514
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw was backing out of the cetra plate in a revision case on (b)(6) 2025.The surgery was for an adjacent level and it was reported that the plate was being removed anyway.The patient was not experiencing any symptoms.It was reported that the locking plate was intact when the device was reomvoed.
Additional Manufacturer Narrative
Product has returned but the investigation is not complete at this time.When the findings become available a follow up report will be submitted.
Additional Manufacturer Narrative
The 4.0mm x 14mm screw (pn: 19-6514, ln: o60) was returned for investigation.Radiographic images were provided to assist with the investigation and confirm that one screw had backed of the construct.The edges of the locking plate that broke off have deformation, likely from contacting the head of the screw.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 found that there is one ncmr (ncmr-101287) for this product lot, but it is not related to this complaint.All other inspections met design specifications.
Event or Problem Description
It was reported that a screw was backing out of the cetra plate in a revision case on (b)(6) 2025.The surgery was for an adjacent level and it was reported that the plate was being removed anyway.The patient was not experiencing any symptoms.It was reported that the locking plate was intact when the device was removed.

• Brand Name: CETRA
• Common Device Name: 4.0MM X 14MM PRIMARY SEMI-CONSTRAINED SELF DRILLING SCREW
• 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: 21633981
• Report Number: 2183449-2025-00007
• Device Sequence Number: 9511047
• Product Code: KWQ
• UDI-Device Identifier: 18257200120321
• UDI-Public: 18257200120321
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 2025
• 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): 05/06/2025

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
• Device Model Number: 19-6514
• Device Lot Number: O60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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: 48 YR
• Patient Sex: Male