Fortilink-C 65-C-1214-6-6LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468080341), received between Aug 6, 2020 and Sep 17, 2021 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, IT WAS REPORTED TO PIONEER SURGICAL TECHNOLOGY THAT A DEATH HAD OCCURRED FOR A PATIENT THAT WAS ENROLLED IN A POST MARKET RETROSPECTIVE CLINICAL STUDY. BASED ON THE LIMITED INFORMATION RECEIVED BY PIONEER SURGICAL TECHNOLOGY, THE PATIENT REPORTEDLY DIED OF A STROKE ON (B)(6) 2020. INITIAL SURGERY FOR THIS PATIENT WAS ON (B)(6) 2019. THERE WAS NO REPORTED EVIDENCE THAT THIS DEATH WAS CAUSED BY THE SURGERY OR PIONEER SURGICAL TECHNOLOGY'S IMPLANT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12488532 ↗
• MalfunctionAug 6, 2020Migration; Migration

  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.

  Patient problems: No Information

  MAUDE report 10376219 ↗