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Fortilink-TS IBF System with TETRAfuse 3D Technology 65-TS-13-26-6LRecalls & reported problems

Pioneer Surgical Technology, Inc. · Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 26mm (L), 6° Lordosis · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468084127), received between Aug 14, 2019 and Aug 14, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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

  • Migration2

Patient problems

  • Pain2

Recent adverse event reports

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

  • InjuryAug 14, 2019Migration; Migration

    IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2019 THAT A FORTILINK-TS IMPLANT MIGRATED POST-OPERATIVELY.

    Patient problems: Pain

    MAUDE report 8895077 ↗
  • InjuryAug 14, 2019Migration; Migration

    IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2019 THAT A FORTILINK-TS CAGE MIGRATED POST-OPERATIVELY. THE PATIENT REPORTEDLY FELT A "POP" AND RETURNED TO THE SURGEON TO BE EVALUATED WHERE IMAGING CONFIRMED SUBSIDENCE OF THE CAGE HAD OCCURRED.

    Patient problems: Pain

    MAUDE report 8895011 ↗

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Sources and updates

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