MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC CETRA; ANTERIOR CERVICAL PLATE

Catalog Number	19-0354
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that the locking mechanism on an implanted cetra 3-level cervical plate failed at level c6.The patient underwent a revision surgery where a corpectomy was required.
Event or Problem Description
Product was returned for investigation.
Additional Manufacturer Narrative
The cetra plate (pn:(b)(4) ln: e11) was returned for investigation.The locking tab sheared off the plate.The locking tab likely failed because of ductile overload and ductile shear overload on the screw.Material deformation was present on the contact edge of the locking tab.The locking tab could have been 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 agile ncmr databases did not reveal any non-conformances related to this investigation.

• Brand Name: CETRA
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: ehab esmail ; 3451 plano parkway; lewisville, TX 75056 ; 2149372015
• MDR Report Key: 15513276
• Report Number: 2183449-2022-00005
• Device Sequence Number: 14747899
• Product Code: KWQ
• UDI-Device Identifier: 18257200120536
• UDI-Public: 18257200120536
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: E11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• 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: 67 YR
• Patient Sex: Female