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

Catalog Number	19-0124
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved is not available for evaluation as it remains implanted.A review of the device history record for cetra plate part number 19-0124, lot e31 was performed which resulted in no anomalies in the device.
Event or Problem Description
Information provided states that the patient underwent an acdf, anterior cervical discetomy and fusion, surgery on (b)(6), 2023.Additional information provided on september 1, states that the surgery was scheduled as a 360 deg procedure performing both anterior and posterior fusion.During the anterior portion of the surgery, after seating the plate, the surgeon attempted to reduce a listhesis when one of the pedical screws pulled through the plate.The screw and plate remain implanted.A secondary surgery is required to complete the posterior segment of the procedure.

• 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 ; 2149372291
• MDR Report Key: 17765546
• Report Number: 2183449-2023-00004
• Device Sequence Number: 15119449
• Product Code: KWQ
• UDI-Device Identifier: 18257200120314
• UDI-Public: 18257200120314
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K162638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/18/2023

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: Health Professional
• Device Catalogue Number: 19-0124
• Device Lot Number: E31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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 Sex: Unknown