Fortilink-C IBF System 65-C-InserterRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846468080228), received between Dec 12, 2024 and Feb 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/16/2025. IT WAS REPORTED THAT THE PROXIMAL PORTION OF A SYSTEM INSERTER HANDLE SEPARATED FROM THE BODY OF THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING THE SYSTEM IMPLANT WITH AN ALTERNATE AVAILABLE INSTRUMENT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 1/17/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381291 ↗
• MalfunctionDec 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/15/2024. IT WAS REPORTED THAT THE PROXIMAL PORTION OF A SYSTEM INSERTER HANDLE SEPARATED FROM THE BODY OF THE INSTRUMENT WHILE BEING USED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING THE SYSTEM IMPLANT WITH AN ALTERNATE AVAILABLE INSTRUMENT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 12/11/2024. THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/15/2024. IT WAS REPORTED THAT THE PROXIMAL PORTION OF A SYSTEM INSERTER HANDLE SEPARATED FROM THE BODY OF THE INSTRUMENT WHILE BEING USED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING THE SYSTEM IMPLANT WITH AN ALTERNATE AVAILABLE INSTRUMENT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 12/11/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924880 ↗
• MalfunctionDec 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/15/2024. IT WAS REPORTED THAT THE PROXIMAL PORTION OF A SYSTEM INSERTER HANDLE SEPARATED FROM THE BODY OF THE INSTRUMENT WHILE BEING USED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING THE SYSTEM IMPLANT WITH AN ALTERNATE AVAILABLE INSTRUMENT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 12/11/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920167 ↗