EIT LLIF Inserter LET20100Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 04260557837702), received between Sep 9, 2020 and Nov 17, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (21 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Material Deformation; Break; Material Deformation

  CONDUIT LLIF TRIAL INSERTER INNER RETAINING SHAFT BENT AND THEN SNAPPED DURING USE. THERE ARE TWO ON THE SET SO THE SECOND INSERTER WAS USED; CONTINUED/FINISHED THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. NO IMPACT ON EXTENDED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574074 ↗
• MalfunctionOct 22, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT FOR INSERTING THE TRIALS HAS THREADS AFFECTED BY NUMEROUS IMPACTS OF THE HAMMER AND THE THREADS HAVE BEEN AFFECTED AND MAY HAVE CAUSED A DENT DUE TO IT. IT IS NOW HARD TO ATTACH THE INSTRUMENTS TOGETHER. SURGICAL TEAM MADE DO WITH WHAT WAS PROVIDED IN THE SET. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359418 ↗
• MalfunctionSep 3, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP) PLEASE DESCRIBE EVENT DETAILS. - DURING THE SET UP FOR THE CASE IT WAS NOTED THAT ONE OF THE INSERTER SHAFTS WAS VERY STIFF TO REMOVE ¿ ITS FINE AS IT DIDN¿T IMPACT THE USE OF THE INSTRUMENT AND THERE WAS ALSO ANOTHER ONE ON THE SET WE COULD USE. HOWEVER THIS NEEDS REPLACING AS IT SHOULD NOT BE THAT STIFF TO REMOVE COULD RESULT IN A INJURY AND EVENTUALLY BREAKING. B. KINDLY PROVIDE THE FOLLOWING PRODUCT DETAILS: - CAN'T READ AS THE INSERTER IS WORN FROM BEING STUCK INSIDE THE OUTER INSERTER TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953357 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE INNER SHAFT OF BOTH TRIALS WERE BENT AND BECAME STUCK IN THE INSERTER WHICH MAKES THE INSTRUMENT IN USABLE. THERE WAS NO IMPACT OR EXTENDED TIME. THE CASE WAS FINISHED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644743 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE INNER SHAFT OF BOTH TRIALS WERE BENT AND BECAME STUCK IN THE INSERTER WHICH MAKES THE INSTRUMENT IN USABLE. THERE WAS NO IMPACT OR EXTENDED TIME. THE CASE WAS FINISHED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644710 ↗
• MalfunctionJun 19, 2025Break; Material Twisted/Bent; Mechanical Jam; Break; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT BOTH TRIAL INSERTERS GOT JAMMED DURING TRIALS. ONE KNOB DID NOT TURN ANYMORE SO INNER SHAFT SNAPPED OFF. THE SECOND ONE GOT DOUBLE THREADED WHICH MADE THE INNER SHAFT SNAP AS WELL. CASE WAS FINISHED WITH NO COMPLICATIONS. THERE WAS NO IMPACT OR EXTENDED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291974 ↗
• MalfunctionJun 19, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT BOTH TRIAL INSERTERS GOT JAMMED DURING TRIALS. ONE KNOB DID NOT TURN ANYMORE SO INNER SHAFT SNAPPED OFF. THE SECOND ONE GOT DOUBLE THREADED WHICH MADE THE INNER SHAFT SNAP AS WELL. CASE WAS FINISHED WITH NO COMPLICATIONS. THERE WAS NO IMPACT OR EXTENDED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291960 ↗
• MalfunctionMar 17, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THE IMPLANT TRIALING PROCESS, BOTH OF THE 3 PART TRIAL INSERTERS JAMMED AND WOULD NOT RELEASE EITHER TRIAL, RENDERING THEM USELESS. AN EXPERIENCED SCRUB NURSE SCRUBBED IN AND AFTER 15 MINUTES OR SO OF FIDDLING AND LUBRICATING MANAGED TO GET THEM WORKING AGAIN, BUT THEY ARE NO LONGER SAFE TO USE AND CANNOT BE USED FOR ANY FURTHER CASES. THERE WAS NO PATIENT IMPACT. THE CASE WAS DELAYED BY 15 MINUTES AND WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617324 ↗
• MalfunctionMar 17, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THE IMPLANT TRIALING PROCESS, BOTH OF THE 3 PART TRIAL INSERTERS JAMMED AND WOULD NOT RELEASE EITHER TRIAL, RENDERING THEM USELESS. AN EXPERIENCED SCRUB NURSE SCRUBBED IN AND AFTER 15 MINUTES OR SO OF FIDDLING AND LUBRICATING MANAGED TO GET THEM WORKING AGAIN, BUT THEY ARE NO LONGER SAFE TO USE AND CANNOT BE USED FOR ANY FURTHER CASES. THERE WAS NO PATIENT IMPACT. THE CASE WAS DELAYED BY 15 MINUTES AND WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617321 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE INSTRUMENT WAS BROKEN. THIS OCCURRED DURING THE PROCEDURE. A SECOND INSTRUMENT WAS USED. THERE WAS NO PATIENT IMPACT WITH NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622450 ↗
• MalfunctionOct 9, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON OCTOBER 3 2024, THE PLASTIC PART IS DAMAGED ON THE THREADS. NO OTHER INFORMATION IS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20409675 ↗
• MalfunctionJun 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2024 , AFTER THE INITIAL IMPACTION AND REMOVAL, THE SCREW/CLAMP OF THE TRIAL INSERTER COULD NO LONGER BE LOOSENED. THE SURGERY WAS COMPLETED AS USUAL AND WITHOUT ANY ISSUES OR IMPACT TO THE PATIENT. THIS REPORT IS FOR A TRIAL INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468407 ↗
• MalfunctionJan 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CONDUIT LLIF TRIAL INSERTER (SHAFT, HANDLE & CAP) AND WOULD NOT COME APART AFTER THE CASE AND ARE JAMMED SOLID. THIS IS A LOAN KIT . THIS HAS HAPPENED BEFORE DURING PREVIOUS CASES. FORTUNATELY THIS DIDN¿T IMPACT THE CASE/OUTCOME AS IT DIDN¿T FAIL DURING THE TRIAL PROCESS. WE USED THE SECOND TRIAL INSERTER ON THE SET TO COMPLETE THE TRIAL PROCESS. THIS REPORT INVOLVES ONE (1) TRIAL INSERTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18446856 ↗
• MalfunctionJan 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CONDUIT LLIF TRIAL INSERTER (SHAFT, HANDLE & CAP) AND WOULD NOT COME APART AFTER THE CASE AND ARE JAMMED SOLID. THIS IS A LOAN KIT . THIS HAS HAPPENED BEFORE DURING PREVIOUS CASES. FORTUNATELY THIS DIDN¿T IMPACT THE CASE/OUTCOME AS IT DIDN¿T FAIL DURING THE TRIAL PROCESS. WE USED THE SECOND TRIAL INSERTER ON THE SET TO COMPLETE THE TRIAL PROCESS. THIS REPORT INVOLVES ONE (1) TRIAL INSERTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18446803 ↗
• MalfunctionDec 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT WAS UNDERGOING A LLIF PROCEDURE. DURING INSERTION OF THE IMPLANT AFTER HAMMERING IT INTO THE RIGHT POSITION, THE KNOB OF THE INSERTER GOT STUCK. THE KNOB WOULDN¿T ROTATE IN EITHER DIRECTION, MAKING IT IMPOSSIBLE TO DETACH IT FROM THE IMPLANT. WHEN THE SURGEON APPLIED FORCE ON THE KNOB, THE INNER SHAFT BROKE. THE SURGEON DECIDED TO KEEP THE IMPLANT IN THE PATIENT, BUT NO FURTHER IMPLANT INSERTERS WERE AVAILABLE, SO THE CAGE WAS NOT OPTIMALLY PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A TRIAL INSERTER. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257513 ↗
• MalfunctionDec 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023 THE PATIENT WAS UNDERGOING A LLIF PROCEDURE. DURING INSERTION OF THE IMPLANT AFTER HAMMERING IT INTO THE RIGHT POSITION, THE KNOB OF THE INSERTER GOT STUCK. THE KNOB WOULDN¿T ROTATE IN EITHER DIRECTION, MAKING IT IMPOSSIBLE TO DETACH IT FROM THE IMPLANT. WHEN THE SURGEON APPLIED FORCE ON THE KNOB, THE INNER SHAFT BROKE. THE SURGEON DECIDED TO KEEP THE IMPLANT IN THE PATIENT, BUT NO FURTHER IMPLANT INSERTERS WERE AVAILABLE, SO THE CAGE WAS NOT OPTIMALLY PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A TRIAL INSERTER. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257505 ↗
• MalfunctionMay 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2023, ONE OF THE CONDUIT LLIF TRIAL INSERTERS WERE STUCK. THE CASE WAS COMPLETED WITH NO PROBLEM AS THE SURGEON WAS ABLE TO USE THE OTHER ONE ON THE SET. THERE WAS MINIMAL DELAY, AND THE PATIENT IS DOING WELL. THIS REPORT INVOLVES ONE TRIAL INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920439 ↗
• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE THREADED PIECE BROKE OFF. NO MORE INSTRUMENT USE IS POSSIBLE. THE SURGERY WAS DELAYED FOR A FEW MINUTES. NO PATIENT DETAILS AVAILABLE; NO PATIENT HARM HAS OCCURRED. THIS REPORT IS FOR ONE (1) TRIAL INSERTER THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770317 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, ITEM LET20100 A IS VERY DIFFICULT TO CONNECT TO ITEM LET20100 C. IT WAS NOTICED DURING THE ROUTINE INSPECTION OF THE LOAN SET IN THE WAREHOUSE. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE TRIAL INSERTER. THIS IS FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456880 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, ITEM LET20100 A IS VERY DIFFICULT TO CONNECT TO ITEM LET20100 C. IT WAS NOTICED DURING THE ROUTINE INSPECTION OF THE LOAN SET IN THE WAREHOUSE. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TRIAL INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454645 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TRIAL INSERTER GOT STUCK ON THE TRIAL AND COULDN¿T BE REMOVED, AS IT WAS CROSS THREADED. THE CASE WENT FINE, WITH NO DELAY AND A GOOD OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TRIAL INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085919 ↗
• MalfunctionNov 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL INSERTER DEVICES WERE DEFECTIVE. THE CUSTOMER WAS NOT ABLE TO ASSEMBLE THE INSTRUMENTS, AND THE HAMMER SHOWED A FRACTURE. NO PATIENT WAS HARMED, AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TRIAL INSERTER. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770020 ↗
• MalfunctionNov 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL INSERTER DEVICES WERE DEFECTIVE. THE CUSTOMER WAS NOT ABLE TO ASSEMBLE THE INSTRUMENTS, AND THE HAMMER SHOWED A FRACTURE. NO PATIENT WAS HARMED, AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TRIAL INSERTER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770014 ↗
• MalfunctionJul 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE IMPLANT TRAY WAS BLOCKED, AND THE TOOL COULD NOT BE DETACHED FROM THE IMPLANT. THE GAUGE FEEDER WAS STUCK AND THE TOOL COULD NOT BE UNFOLDED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. THIS REPORT IS FOR ONE (1) TRIAL INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103648 ↗
• MalfunctionJul 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A MINI ALIF PROCEDURE (AS PER MAYER/ L4/5 / ACCESS FROM THE RIGHT, LEFT LATERAL POSITION), AFTER INSERTING THE CONDUIT LLIF CAGE, IT WAS NOT POSSIBLE TO DETACH THE INSERTION INSTRUMENT FROM THE CAGE. THE INSERTION INSTRUMENT BLOCKED THE CAGE AND IT COULD NOT BE RELEASED. THE CAGE WAS REMOVED WITH HELP OF THE IMPLANT-POSITIONING INSTRUMENT. ANOTHER FREESTYLE CAGE WAS INSERTED WITH THE HELP OF AN IMPLANT-PUSHER. THE TRIAL IMPLANT HOLDER ALSO JAMMED DURING DISASSEMBLY AND WAS BLOCKED COMPLETELY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE, SURGERY WAS DELAYED FOR APPROXIMATELY 15 MINUTES. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR A TRIAL INSERTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102764 ↗