CONDUIT PET30101TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034558097), received between Apr 12, 2023 and May 12, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Mechanical Jam

  IT WAS REPORTED THAT THE INNER SHAFT WAS STUCK IN THE IMPLANT HOLDER AND WAS IMPOSSIBLE TO REMOVE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148440 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, UPON CAGE INSERTION, THE INNER THREADS COLD-WELDED TO THE INSERTER AND THE CAGE WAS UNABLE TO BE RELEASED. THE SURGERY WAS DELAYED BY 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694468 ↗
• MalfunctionOct 1, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2024 DURING POST-OP INSPECTION, SEVERAL INSTRUMENTS WERE FOUND TO BE WORN OR DAMAGED. T-HANDLE HAS A CROSS THREADED INNER DRIVER ATTACHED. TRIAL WON¿T LOAD PROPERLY ONTO THE TRIAL HANDLES. NO COMPLAINTS WERE NOTED DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343863 ↗
• MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON POST CASE INSPECTION, THE T-HANDLE INNER THREAD COLD WELDED INTO T-HANDLE INSERTER. IT WAS UNABLE TO TAKE APART, AND THERE WAS NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) OF TWO (2) T HANDLE INSERTER FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20175757 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  PATIENT STATUS AND OUTCOME RESULTED IN THE CAGE BEING REMOVED THE FOLLOWING DAY THROUGH AN ENDOSCOPIC ANTERIOR PROCEDURE. NO ISSUES WERE NOTED.

  Patient problems: Insufficient Information

  MAUDE report 18776499 ↗
• MalfunctionFeb 19, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONDUIT PLIF INSERTERS IN QUESTION WERE UNABLE TO BE ASSEMBLED DUE TO THREAD MALFORMATION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONDUIT STRAIGHT TLIF/PLIF TRANSFORAMINAL/POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730580 ↗
• MalfunctionJan 12, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING POSTOP INSPECTION, IT WAS NOTED THAT THE INNER THREADS ON THE CONDUIT PLUF INSERTER AND INNER SHAFT WERE DAMAGED TO THE POINT OF NOT FUNCTIONING. ALSO, THE PLASTIC TIP OF THE MALLET WAS BROKEN OFF, LEAVING THE THREADS BEHIND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503160 ↗
• MalfunctionJan 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BACK PIN OF THE CONDUIT INSERTER WAS DIFFICULT TO TAKE APART AFTER A SPINE SURGERY. THE EVENT CAUSED NO ISSUE DURING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502047 ↗
• MalfunctionNov 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT UPON INSPECTION POST DECONTAMINATION, THE T HANDLE INSERTER AND INNER THREAD WOULD NOT COME APART. THE INNER THREAD WAS LODGED STUCK IN THE T HANDLE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT. THIS IS REPORT 2 OF 4 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046862 ↗
• MalfunctionNov 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT UPON INSPECTION POST DECONTAMINATION ON (B)(6) 2023, THE T HANDLE INSERTER AND INNER THREAD WOULD NOT COME APART. THE INNER THREAD WAS LODGED STUCK IN THE T HANDLE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046860 ↗
• MalfunctionSep 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE CONDUIT TLIF CAGE INSERTER BECAME LODGED TOGETHER. THE EVENT OCCURRED AFTER THE CAGE WENT INTO THE PATIENT. THE THREADED INSERT WOULDN¿T COME OUT OF THE OUTER SHAFT. THERE WAS NO HARM TO THE PATIENT, AND NO DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS REPORTED TO BE DOING WELL. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17758893 ↗
• MalfunctionApr 12, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING POSTERIOR SPINAL FUSION PROCEDURE WHILE INSERTING THE CAGE THE TIP OF THE INSERTER BROKE OFF AND THE THREADED INNER SHAFT LOCKED ONTO THE CAGE. PLIERS USED TO LOOSEN INSERTER AND MICRO PITUITARY USED TO GRAB THE BROKEN PIECE OF THE INSERTER. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN PLIERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1)T HANDLE INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724299 ↗