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

Model Number	65-C-1517-6-6L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 on (b)(6) 2020 that during a clinical study of the fortilink-c system, it was discovered that a patient had a c6 screw loosen post-operatively.The loosening was confirmed via x-ray on (b)(6) 2020.Index surgery was performed on (b)(6) 2019.There are no plans to revise at this time.This report will be updated should additional information become available at a later date.

• 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
• MDR Report Key: 10376035
• Report Number: 1833824-2020-00034
• Device Sequence Number: 2898590
• Product Code: MAX
• UDI-Device Identifier: 00846468080419
• UDI-Public: (01)00846468080419(17)231031(10)329635
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 10/31/2023
• Device Model Number: 65-C-1517-6-6L
• Device Catalogue Number: SAME
• Device Lot Number: 329635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/06/2020
• 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