Fortilink-L IBF System with TETRAfuse 3D Technology 65-L-2250-13-6LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468085957), received between May 18, 2022 and May 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

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

• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SURGALIGN DIRECTOR OF (B)(6) INFORMED US OF A COMPLAINT INVOLVING A STUDY PATIENT, "DATE OF EVENT: 3-23-2022. SUBJECT PRESENTS TODAY WITH WORSENING LOW BACK PAIN AND EXTENDS INTO HER BUTTOCKS. THE PAIN IMPROVES WHENEVER THE PATIENT BENDS IN A FORWARD POSITION. THE L4-5 POSTERIOR INSTRUMENTATION DEMONSTRATES TO BE STABLE. SUBJECT IS GETTING AN UPDATED MRI TO FURTHER EVALUATE THE PATHOLOGY. ONCE THE EXAM HAS BEEN COMPLETED SHE WILL FOLLOW UP WITH HER DOCTOR TO REVIEW THE RESULTS AND DECIDE ON ANY FURTHER TREATMENT. SUBJECT STATED THE PAIN BEGAN ABOUT A YEAR AGO, BUT COULD NOT GIVE A PARTICULAR DATE. DATE OF SURGERY: 11-7-2019."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Unspecified Musculoskeletal problem

  MAUDE report 14429037 ↗