EIT TLIF Inserter TFT20101Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 04260557775578), received between Mar 29, 2019 and Sep 23, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (20 reports).

2 other recalls cover devices cleared under the same FDA submission (K170503); they may or may not involve this specific model.

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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50872990 ↗
• MalfunctionJan 14, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  WHEN INSERTING THE TRIAL CAGE INTO THE PATIENT, THE TRIAL KEPT TURNING PREMATURELY. THE TRIAL WOULD BECOME LOOSE FROM THE HANDLE AND WOULD HAVE TO BE REPOSITIONED. THIS WAS ALSO HAPPENING WITH THE ACTUAL IMPLANT INSERTER; UPON INSERTION THE IMPLANT WOULD TURN PREMATURELY AND WOULD HAVE TO BE REPOSITIONED AND TIGHTENED AGAIN. THERE ARE NO KNOWN ADVERSE CONSEQUENCES FOR THE PATIENT. THE PATIENT IS UP AND WALKING, PAIN FREE AND READY TO BE DISCHARGED FROM HOSPITAL AS OF (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152335 ↗
• MalfunctionDec 13, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE OUTER PART OF THE TEST CAGE INSERTER IS BENT SO THAT THE INNER PART CANNOT SLIP INTO ITS SHAFT. THEREFORE, ONE CANNOT ATTACH TO A SAMPLE CAGE AND/OR USE THE INSTRUMENT. IT IS UNKNOWN HOW THIS HAPPENED, AS THE INSTRUMENT WAS ON LOAN FROM A HOSPITAL FOR SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20927640 ↗
• MalfunctionMar 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2024, THE INNER SHAFT OF THE CONDUIT TRIAL INSERTER DIDN¿T ENTER PROPERLY IN THE OUTER SHAFT INSERTER. FOR THAT REASON, THE INNER SHAFT DIDN¿T FIX CORRECTLY TO THE KNOB THAT IS ATTACHED IN THE BACK PART OF THE YELLOW INSERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824936 ↗
• MalfunctionFeb 5, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: THE INNER PIN PART OF THE TRIAL IMPLANT BROKE WHEN THE SCRUB NURSE WAS ATTACHING THE TRIAL. BEFORE ANY HAMMERING TO INTRODUCE THE TRIAL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT : (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18645069 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SALES CONSULTANT RECEIVED A SET FROM THE LOANER WAREHOUSE AND IT CONTAINED DAMAGED PIECES. ITEMS WERE BROKEN UPON RECEIVING. INFORMED THE LOANERS DEPARTMENT OF WHAT WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586967 ↗
• MalfunctionJan 25, 2024Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2024, THE CONDUIT TLIF TRIAL INNER SHAFT (BALL END) BENT/BROKEN AT THE END. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582577 ↗
• MalfunctionSep 13, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT TRIAL KEY BROKEN. THERE WAS NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736685 ↗
• MalfunctionSep 11, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE CUSTOMER RECEIVED MODULE MSTLIF4N BUILD 8 ON 07/08,WHICH CONTAINED 2 ITEMS THAT WERE STILL DIRTY. THESE ARE: 1 X TFT30101 LOT NO. E21D10137. 1 X TFT20101 LOT NO. E21D10136. SOLUTION: SETS HAVE NOT BEEN SENT OUT AGAIN. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725483 ↗
• MalfunctionAug 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE HANDLE OF THE TRIAL INSERTER DIDN'T FIT THE SLAM HAMMER BECAUSE IT´S SMALLER. THERE WAS A TEN (10) MINUTES OF SURGICAL DELAY. THE INSERTER WAS REMOVED CAREFULLY WITHOUT THE SLAM HAMMER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568424 ↗
• MalfunctionFeb 2, 2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283576 ↗
• MalfunctionFeb 2, 2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283562 ↗
• MalfunctionFeb 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE TRIAL AND IMPLANT HOLDER FROM THE CONDUIT TLIF SET WERE ALMOST IMPOSSIBLE TO ASSEMBLE. WITH A LOT OF FORCE, ONE IMPLANT HOLDER AND ONE TRIAL HOLDER WERE ABLE TO BE ASSEMBLED. CONSIDERING THE PROBLEM, THE SURGEON DIDN¿T FEEL SECURE TO DO A TLIF AND FINALLY SWITCHED TO PLIF. SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TRIAL INSERTER SH CONNECTION. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278085 ↗
• MalfunctionFeb 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE TRIAL AND IMPLANT HOLDER FROM THE CONDUIT TLIF SET WERE ALMOST IMPOSSIBLE TO ASSEMBLE. WITH A LOT OF FORCE, ONE IMPLANT HOLDER AND ONE TRIAL HOLDER WERE ABLE TO BE ASSEMBLED. CONSIDERING THE PROBLEM, THE SURGEON DIDN¿T FEEL SECURE TO DO A TLIF AND FINALLY SWITCHED TO PLIF. SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277963 ↗
• MalfunctionFeb 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON DURING A SPINAL FUSION PROCEDURE ON (B)(6), 2023, THE TRIAL AND IMPLANT HOLDER FROM THE CONDUIT TLIF SET WERE ALMOST IMPOSSIBLE TO ASSEMBLE. WITH A LOT OF FORCE, ONE IMPLANT HOLDER AND ONE TRIAL HOLDER WERE ABLE TO BE ASSEMBLED. CONSIDERING THE PROBLEM, THE SURGEON DIDN¿T FEEL SECURE TO DO A TLIF AND FINALLY SWITCHED TO PLIF. SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277950 ↗
• MalfunctionJul 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE SURGEON WAS TRIALING EIT CONDUIT CAGE WITH THE APPROPRIATE TRIAL INSERTER (TFT20101) WITH A 10MM (TFT81030) TRIAL. UPON TIGHTENING THE TRAIL AS PER THE SURGICAL TECHNIQUE, THE INNER SHAFT OF THE TRIAL SHEARED, LEAVING THE TRIAL AND THE BROKEN INSERT INSIDE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075658 ↗
• MalfunctionApr 13, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE INTERNAL SHAFT OF THE TEST APPLICATOR BROKE DURING THE INSERTION, SO IT WAS NECESSARY TO USE OTHER INSTRUMENTS TO REMOVE IT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TRIAL INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102369 ↗
• MalfunctionApr 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE CONDUIT TLIF TRIAL IMPLANT HOLDER WAS DIFFICULT TO DISASSEMBLE FOLLOWING SURGERY. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR DELAYS IN SURGERY. THIS REPORT INVOLVES ONE (1) TRIAL INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083818 ↗
• MalfunctionMar 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING SURGERY THE INTERNAL SHAFT OF THE TRIAL INSERTER BROKE INSIDE THE HANDLE AND THE ENTIRE KEY NEEDED TO BE CHANGED. THE INNER SHAFT IMPLANT INSERTER WAS GROUND. THERE WERE NO FRAGMENTS GENERATED. THE SURGERY WAS SUCCESSFULLY COMPLETED BUT THE TRIALS WERE NOT USED. THIS REPORT INVOLVES ONE TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723840 ↗
• MalfunctionFeb 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, BEFORE SURGERY THE NURSE REALIZED THAT THE SHAFT OF INSTRUMENT COULD NOT BE INSERTED. SURGERY WAS DONE WITH THE SECOND IDENTICAL INSTRUMENT IN THE SET. AFTER SURGERY THE NURSE WAS NOT ABLE TO REMOVE THE SHAFT FROM THE INSTRUMENT USED DURING THE SURGERY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606610 ↗
• MalfunctionFeb 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, BEFORE SURGERY THE NURSE REALIZED THAT THE SHAFT OF INSTRUMENT COULD NOT BE INSERTED. SURGERY WAS DONE WITH THE SECOND IDENTICAL INSTRUMENT IN THE SET. AFTER SURGERY THE NURSE WAS NOT ABLE TO REMOVE THE SHAFT FROM THE INSTRUMENT USED DURING THE SURGERY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606547 ↗
• MalfunctionFeb 21, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PRODUCT WAS FOUND TO BE DEFECTIVE. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13568935 ↗
• MalfunctionJan 12, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE INTRUMENT¿S INNER SHAFT WAS FOUND TO BE BENT. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT INVOLVES ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236136 ↗
• MalfunctionJan 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER AN UNKNOWN PROCEDURE, A CRACK IN THE YELLOW HANDLE OF THE TRIAL IMPLANT INSERTER WAS DISCOVERED. NO PROCEDURE OR PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169071 ↗
• MalfunctionJan 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SPINAL PROCEDURE, THE TRIAL IMPLANT DISENGAGED FROM THE TRIAL INSERTER DURING USE. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REATTACHING THE TRIAL IMPLANT TO THE TRIAL IMPLANT HOLDER. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 2 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152126 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

• Z-1323-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
• Z-1324-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD