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

Catalog Number	19-0236
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that the locking mechanism on a cervical plate became dislodged.A revision surgery was performed to replace the plate and screws.
Event or Problem Description
Product was returned for investigation.
Additional Manufacturer Narrative
The cetra plate (pn:19-0232 ln:e08) was returned for investigation.It was reported that 1 locking tab broke in-situ.The case was c4/6 and it was at c6 that it broke (break occurred at the caudal end).The locking tab had sheared off at the location of smallest cross-section in the design.Failure likely occurred because of ductile overload of the locking tab.The locking tab could have been subjected to overload due to screws left proud or extreme angulation.The cetra operative technique contains this note in section 10 (screw locking mechanism) - "note: confirm that all screws have been fully seated in the plate before locking." proud screws create unintended contact and loading with the locking tab.One of the locking tabs that is broken shows contact marks with the 2 screws at that level.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: CETRA 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: 15508931
• Report Number: 2183449-2022-00004
• Device Sequence Number: 17571977
• Product Code: KWQ
• UDI-Device Identifier: 18257200120383
• UDI-Public: 18257200120383
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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 Expiration Date: 07/23/2023
• Device Catalogue Number: 19-0236
• Device Lot Number: E08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2018
• 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: 37 YR
• Patient Sex: Male