MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER FORTILINK-C TETRAFUSE; INTERVERTEBRAL FUSION DEVICE

Model Number	65-C-1517-7-6L
Health Effect - Clinical Code	Dysphasia (2195)
Date of Event	08/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains implanted in patient.The device was not returned to rti surgical for evaluation.A dhr review was conducted and confirms the device met manufacturing specification prior to shipping from rti surgical facility.This report will be updated should information become available at a later date.
Event or Problem Description
It was reported to rti surgical that during a clinical study it was discovered that a patient experienced post-operative dysphagia two days following a fortilink-c surgery performed on (b)(6) 2019.The procedure and event occurred over a year ago but the customer had recently been at the site to review data and found this incident in their records.The subject has not had any other device or procedure related adverse events and has not had any revision surgeries.

• Brand Name: PIONEER FORTILINK-C TETRAFUSE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 11728864
• Report Number: 1833824-2021-00036
• Device Sequence Number: 4545230
• Product Code: MAX
• UDI-Device Identifier: 00846468080426
• UDI-Public: (01)00846468080426(17)240214(10)337597
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/26/2021

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 Expiration Date: 02/24/2024
• Device Model Number: 65-C-1517-7-6L
• Device Catalogue Number: SAME
• Device Lot Number: 337597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/26/2021
• 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: Other