CONDUIT PET30102TRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034558073), received between Dec 16, 2022 and Jan 30, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Mechanical Jam

  IT WAS REPORTED THAT THE T-HANDLE INSERTER DOES NOT ALLOW ROTATION WITH THE INNER SHAFT. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222612 ↗
• MalfunctionJan 30, 2026Mechanical Jam

  IT WAS REPORTED THAT THE T-HANDLE INSERTER DOES NOT ALLOW ROTATION WITH THE INNER SHAFT. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222608 ↗
• 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 23694737 ↗
• MalfunctionJun 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS BENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338501 ↗
• MalfunctionJun 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS BENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338494 ↗
• 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 TWO (2) OF TWO (2) T HANDLE INSERTER FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176519 ↗
• MalfunctionMar 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON UNKNOWN DATE, DURING AN L2-5 POSTERIOR LUMBAR INTERBODY FUSION, SURGEON INSERTED CONDUIT CAGE ITEM INTO THE L2-3 DISC SPACE ON THE LEFT HAND SIDE. HE UNTHREADED THE IMPLANT HOLDER THEN DECIDED THAT HE WANTED TO PULL THE CAGE POSTERIOR 2MM SO HE ATTEMPTED TO REENGAGE THE IMPLANT HOLDER ONTO THE CAGE. HE STRUGGLED TO REENGAGE THE HOLDER, AND DUE TO DOWNWARD FORCE HE PUSHED THE CAGE ANTERIOR AND LATERAL TO THE DISC SPACE. HE TRIED TO RETRIEVE THE CAGE BUT WAS UNSUCCESSFUL. AFTER NUMEROUS ATTEMPTS TO GET ACCESS TO PULL THE CAGE BACK HE DECIDED TO MOVE FORWARD WITH FINISHING THE PROCEDURE AND INSTEAD HAVE A DIFFERENT SPECIALTY RETRIEVE THE CAGE AT A LATER TIME THROUGH AN ANTERIOR RETROPERITONEAL APPROACH. SURGEON THEN FINISHED THE PROCEDURE WITH NO ISSUES. THE PATIENT NEEDS TO RETURN TO THE OPERATING ROOM TO HAVE THE CAGE REMOVED ( ON (B)(6) 2024) THERE WAS A 60-90 MINUTE SURGICAL DELAY. GENERAL AND VASCULAR SURGEONS WERE CALLED TO UNDERSTAND THE ISSUE AND CREATE A PLAN FOR RETRIEVING THE CAGE AT A LATER TIME. THE GENERAL AND VASCULAR SURGEONS CAME TO THE OPERATING ROOM TO SEE IF THE CAGE COULD BE REMOVED POSTERIORLY. THEY DECIDED IT COULD NOT SO THE PLAN CHANGED TO T

  Patient problems: Insufficient Information

  MAUDE report 18895289 ↗
• 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 2 OF 2 FOR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730583 ↗
• 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 INNER SHAFT . THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503161 ↗
• MalfunctionNov 14, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON CAGE INSERTION, THE INNER SHAFT TO THE T HANDLE INSERTER BROKE INTRAOPERATIVELY. THIS HAPPENED WITH MULTIPLE INNER SHAFTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. PATIENT OUTCOME WAS SUCCESSFUL WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR (B)(4). FOR T HANDLE INSERTER INNER SHAFT.

  Patient problems: Insufficient Information

  MAUDE report 18133896 ↗
• MalfunctionNov 14, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON CAGE INSERTION, THE INNER SHAFT TO THE T HANDLE INSERTER BROKE INTRAOPERATIVELY. THIS HAPPENED WITH MULTIPLE INNER SHAFTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. PATIENT OUTCOME WAS SUCCESSFUL WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR (B)(4). FOR T HANDLE INSERTER INNER SHAFT.

  Patient problems: Insufficient Information

  MAUDE report 18133893 ↗
• MalfunctionNov 14, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON CAGE INSERTION, THE INNER SHAFT TO THE T HANDLE INSERTER BROKE INTRAOPERATIVELY. THIS HAPPENED WITH MULTIPLE INNER SHAFTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. PATIENT OUTCOME WAS SUCCESSFUL WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR (B)(4). FOR T HANDLE INSERTER INNER SHAFT.

  Patient problems: Insufficient Information

  MAUDE report 18133880 ↗
• 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 INNER SHAFT. THIS IS REPORT 4 OF 4 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046858 ↗
• 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 INNER SHAFT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046853 ↗
• 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 INNER SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17758892 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON CAGE INSERTION, THE PMIN T-HANDLE INSERTERS BROKE. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER INNER SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17693271 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2023, UPON CAGE INSERTION, THE PMIN T-HANDLE INSERTERS BROKE. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER INNER SHAFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692694 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON CAGE INSERTION, THE PMIN T-HANDLE INSERTERS BROKE. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE CONDUIT STRAIGHT TLIF / PLIF TRANSFORAMINAL / POSTERIOR LUMBAR INTERBODY IMPLANT INSERTER INNER SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692690 ↗
• MalfunctionDec 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, POST CASE, UPON REASSEMBLY, THE T HANDLE INSERTER INNER THREAD WOULD NOT PROPERLY THREAD INTO THE T HANDLE. IT GOT STUCK UPON REINSERTION. THE PATIENT DID NOT EXPERIENCE A POST OP DEVICE MALFUNCTION OR ADVERSE EVENT. THE PATIENT DOES NOT REQUIRE ANY REMOVAL SURGERY. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) T HANDLE INSERTER INNER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999092 ↗