Fortilink-C IBF System 65-C-1517-8-6LRecalls & reported problems
Pioneer Surgical Technology, Inc. · Interbody Fusion Device · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191083006727), received between Aug 12, 2024 and Aug 12, 2024 — classified as 2 deaths.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Cardiac Arrest2
- Pulmonary Embolism2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A 4-LEVEL ACDF PROCEDURE WAS COMPLETED SUCCESSFULLY AND DURING THE FLIP OF THE PATIENT A CARDIAC ARREST EVENT HAPPENED AND THE PATIENT EXPIRED. IT WAS CONFIRMED THAT THIS WAS NOT A PRODUCT RELATED EVENT.
Patient problems: Cardiac Arrest; Pulmonary Embolism
MAUDE report 19964929 ↗DeathAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A 4-LEVEL ACDF PROCEDURE WAS COMPLETED SUCCESSFULLY AND DURING THE FLIP OF THE PATIENT A CARDIAC ARREST EVENT HAPPENED AND THE PATIENT EXPIRED. IT WAS CONFIRMED THAT THIS WAS NOT A PRODUCT RELATED EVENT.
Patient problems: Cardiac Arrest; Pulmonary Embolism
MAUDE report 19964325 ↗
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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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