Fortilink-C 65-C-1517-7-6LRecalls & reported problems
Pioneer Surgical Technology, Inc. · FORTILINK-C Tetrafuse 14.5x17 7mm, 6L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468080426), received between Aug 6, 2020 and Apr 26, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Dysphasia1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2021Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Dysphasia
MAUDE report 11728864 ↗MalfunctionAug 6, 2020Fracture; Fracture
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 SCREW FRACTURE POST-OPERATIVELY. THE FRACTURE 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 10372463 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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