MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM; STANDARD 3-LEVEL PLATE

Model Number	66-348
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to rti surgical and inspections confirmed the separation of the plate locking mechanism.A dhr review was conducted and confirms that the device met manufacturing specifications prior to shipping from rti surgical.
Event or Problem Description
It was reported to rti surgical on 12/07/2020 that a revision had already been performed due to a post-operative locking mechanism failure for this implant.It was confirmed that the locking mechanism separated post-operatively.The date of the failure is unknown.The date of the index surgery was (b)(6) 2020.The date of the revision surgery was (b)(6) 2020.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: STANDARD 3-LEVEL PLATE
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 11120108
• Report Number: 1833824-2021-00003
• Device Sequence Number: 17124327
• Product Code: KWQ
• UDI-Device Identifier: 00846468087449
• UDI-Public: (01)00846468087449(10)354405
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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: Health Professional
• Device Model Number: 66-348
• Device Catalogue Number: SAME
• Device Lot Number: 354405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention