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Fortilink-L IBF System with TETRAfuse 3D Technology 65-L-1845-13-12LRecalls & reported problems

Pioneer Surgical Technology, Inc. · Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 45mm (L), 13mm (H), 12° Lordosis · 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 00846468086534), received between Dec 1, 2021 and Dec 1, 2021 — 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

  • Drug Resistant Bacterial Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT DEVELOPED (B)(6) WITH WOUND INFECTION AND UNDERWENT A WOUND WASHOUT ON (B)(6) 2020. PATIENT WAS TREATED WITH CEFAZOLIN AND RIFAMPIN. AT (B)(6) 2020 CLINIC VISIT, IT WAS NOTED THAT WOUND WAS HEALING WELL WITH A VERY SMALL AMOUNT OF PERSISTENT BUT IMPROVING YELLOWISH DRAINAGE AT THE UPPER POLE OF INCISION.

    Patient problems: Drug Resistant Bacterial Infection

    MAUDE report 12913479 ↗

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Sources and updates

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