Fortilink-TS IBF System with TETRAfuse 3D Technology 65-TS-13-22Recalls & reported problems
Pioneer Surgical Technology, Inc. · Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 22mm (L) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468084097), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 injury.
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
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2020 THAT DURING A CLINICAL STUDY OF THE FORTILINK-TS SYSTEM IT WAS DISCOVERED THAT A REVISION SURGERY HAD TAKEN PLACE DUE TO PATIENT PAIN, NON-UNION, AND NON-FUSION. THE INDEX SURGERY WAS PERFORMED ON (B)(6) 2019 FOR INCREASING RIGHT L5-S1 FORAMINAL STENOSIS. FOLLOWING SURGERY, THE PATIENT CONTINUED TO EXPERIENCE BACK PAIN. REVISION WAS THEN PERFORMED ON (B)(6) 2020.
Patient problems: Pain
MAUDE report 10459757 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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