CONDUIT TFT20103TRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034557960), received between Sep 16, 2024 and Apr 23, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A RESISTANCE WHEN INSERTING THE INNER SHAFT INTO THE OUTER SHAFT. THERE WAS NO PATIENT CONSEQUENCE. THE SURGERY PROCEEDED AS PLANNED USING AN ALTERNATIVE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967818 ↗
• MalfunctionAug 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE TLIF TRIAL INSERTER CANNOT BE ASSEMBLED ANYMORE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862708 ↗
• MalfunctionAug 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE TLIF TRIALINSERTER CANNOT BE ASSEMBLED ANYMORE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862686 ↗
• MalfunctionMay 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A TLIF MIS PROCEDURE ON (B)(6) 2025 THE INSTRUMENT FOR BOTH TRAIL AND FINAL INSERTION OF THE IMPLANT BECAME DAMAGED IN A WAY THAT IT IS NOT LONGER USABLE FOR FUTURE CASES. NO PATIENT CONSEQUENCES. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY OR COMPLICATION. THE CONCOMITANT DEVICE WAS RECEIVED AND IT WAS DETERMINED THERE WAS A DEVICE INTERACTION ISSUE. PRODUCT WAS RAISED UP TO DOCUMENT IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009237 ↗
• MalfunctionJan 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL INSERTER COULD NOT BE ASSEMBLED WHEN PREPARING THE SURGERY. THE INLINE DOES NOT GO THROUGH THE OUTER SHAFT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275220 ↗
• MalfunctionJan 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL INSERTER COULD NOT BE ASSEMBLED WHEN PREPARING THE SURGERY. THE INLINE DOES NOT GO THROUGH THE OUTER SHAFT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275217 ↗
• MalfunctionDec 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON NOVEMBER 12, 2024, THE TLIF CONDUIT TRIAL INSERTER COULDN¿T BE MOUNTED ANYMORE. THE INLINE DOESN¿T FIT THROUGH THE HOLE IN TRIAL INSERTER OUTERSHAFT. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039801 ↗
• MalfunctionDec 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2024, THE TLIF CONDUIT TRIAL INSERTER COULDN¿T BE MOUNTED ANYMORE. THE INLINE DOESN¿T FIT THROUGH THE HOLE IN TRIAL INSERTER OUTERSHAFT. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039631 ↗
• MalfunctionOct 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE INSERTER WAS BENT WHILE INSERTING TRIAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20545343 ↗
• MalfunctionSep 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRA-OP EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247012 ↗
• MalfunctionSep 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRA-OP EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246932 ↗
• MalfunctionSep 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED AT THE END OF THE SURGERY, ON AN UNKNOWN DATE, IT WAS HARD TO DISASSEMBLE THE TRIAL INSERTER INNER SHAFT FROM THE TRIAL INSERTER OUTER SHAFT. IT LOOKS LIKE THE DISTAL TIP OF THE OUTER SHAFT IS SLIGHTLY WORN/TORN, THUS PREVENTING THE BALL TIP OF THE INNER SHAFT TO SLIDE IN/OUT. THERE WAS NO IMPACT ON THE PATIENT OR SURGERY. THIS REPORT IS FOR ONE CONDUIT CURVED TLIF TRANSFORAMINAL LUMBAR INTERBODY TRIAL INSERTER INNER SHAFT FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226182 ↗
• MalfunctionSep 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED AT THE END OF THE SURGERY, ON AN UNKNOWN DATE, IT WAS HARD TO DISASSEMBLE THE TRIAL INSERTER INNER SHAFT FROM THE TRIAL INSERTER OUTER SHAFT. IT LOOKS LIKE THE DISTAL TIP OF THE OUTER SHAFT IS SLIGHTLY WORN/TORN, THUS PREVENTING THE BALL TIP OF THE INNER SHAFT TO SLIDE IN/OUT. THERE WAS NO IMPACT ON THE PATIENT OR SURGERY. THIS REPORT IS FOR ONE CONDUIT CURVED TLIF TRANSFORAMINAL LUMBAR INTERBODY TRIAL INSERTER INNER SHAFT FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223370 ↗