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

Model Number	66-228
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003); Separation Problem (4043)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was conducted and confirms this device met manufacturing specifications prior to shipping from rti surgical.Inspection results for the plate observed cracks and excessive damage from mechanical instrumentation.Dimensional inspection passed with measurements meeting manufacturing specifications.
Event or Problem Description
It was reported to rti surgical on 4/19/2021 that a post-operative screw backout had occurred due to separation of the plate locking mechanism.Index surgery took place on (b)(6) 2020.Revision surgery was conducted on (b)(6) 2021.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: STANDARD CERVICAL PLATE
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 11809235
• Report Number: 1833824-2021-00037
• Device Sequence Number: 3659154
• Product Code: KWQ
• UDI-Device Identifier: 00846468087340
• UDI-Public: (01)00846468087340(10)352676
• Combination Product (Y/N): N
• 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: 2021
• 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): 05/11/2021

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 Expiration Date: 12/03/2019
• Device Model Number: 66-228
• Device Catalogue Number: SAME
• Device Lot Number: 352676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: Hospitalization; Required Intervention