EIT TLIF Inserter TFT30101Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 04260557775592), received between Mar 28, 2019 and Jan 26, 2026 — classified as 8 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT THE CONDUIT CURVED INSERTER SHAFT BROKE. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184571 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT THE CONDUIT CURVED INSERTER SHAFT BROKE. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184546 ↗
• MalfunctionJan 20, 2026Break; Entrapment of Device

  IT WAS REPORTED DURING A MIS DEGENERATIVE CASE, WHERE A CONDUIT TLIF CAGE WAS INSERTED AND ISSUE OCCURRED WITH THE INSERTER. UPON LOOSENING THE INSERTION INSTRUMENT TO PIVOT THE CAGE IN THE DISC SPACE (AS INTENDED AND IN ACCORDANCE TO THE STG) THE TIP OF THE INNER SHAFT BROKE OFF. THIS TIP REMAINED IN THE CAGE (INSERTED IN THE DISC SPACE). THE SURGEON TRIED TO RETRIEVE THE BROKEN TIP, BUT AS IT WAS STUCK IN THE CAGE, AND COULD NOT MOVE, THE SURGEON DECIDED TO LEAVE THE PART IN THE CAGE. IN ORDER TO MAKE SURE THE PART WOULD NOT MOVE, THE CAGE OPENING WAS SEALED WITH BONE WAX. ADDITIONAL BONE WAS INSERTED ON THE CAGE. THIS WILL LOCK THE PART IN THE CAGE. REMOVAL OF THE CAGE WAS NOT POSSIBLE DUE TO THE PART BLOCKING A SECOND INSERTER TO BE ATTACHED TO THE IMPLANT. NO CONSEQUENCE FOR THE PATIENT. NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24118482 ↗
• MalfunctionNov 3, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED WHILE INSERTING THE CONDUIT TLIF INTO THE DISC SPACE, THE CAGE INSERTER TIP BROKE INSIDE THE CAGE. DURING SURGERY, IT WAS NOT POSSIBLE TO REMOVE IT FROM INSIDE THE CAGE. SURGERY WAS DELAYED 20 MINUTES. FRAGMENTS WERE GENERATED AND IT WAS NOT POSSIBLE TO REMOVE THE TIP. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23455009 ↗
• MalfunctionAug 14, 2025Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT HAPPENED DURING INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803601 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE INTERNAL ROD OF THE DEFINITIVE CAGE CONDUIT HANDLE WAS BROKEN. THE DAMAGE HAPPENED JUST IN THE UNION IN WHICH THE ROD IS LOCATED. A PART OF THE ROD REMAINED INSIDE THE HANDLE, BEING IMPOSSIBLE TO REMOVE IT. DOCTOR WAS NOT SATISFIED WITH THE POSITION IN WHICH THE CAGE REMAINED. IT WAS NOT POSSIBLE TO PLACE THE CAGE IN A GOOD WAY. THERE WAS A 30 MINUTES OF SURGICAL DELAY. THE DOCTOR COULDN'T FINISH PLACING THE CAFE CONDUIT PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 22708857 ↗
• MalfunctionJan 17, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON(B)(6) 2025. THE IMPLANT INSERTER INNER SHAFT OF THE CONDUIT TLIF BROKE AFTER SEVERAL TIMES PUTTING THE IMPLANT ON AND REMOVING IT. IT WAS NO LONGER POSSIBLE TO ROTATE THE IMPLANT. A NEW IMPLANT INSERTER WAS USED. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183142 ↗
• 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 21152324 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024 THAT DURING THE ATTACHMENT OF THE CONDUIT HANDLE, THE INNER SHAFT BROKE ON THE TRANSITION FROM THE THREADED TO THE NON-THREADED PART. ONE PART OF THE INNER SHAFT REMAINED STUCK ON THE HANDLE. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. THE SECOND HANDLE THAT IS PART OF THE SET WAS USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602064 ↗
• MalfunctionApr 18, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON MARCH 1, 2024 THE DRIVERS STRIPPED DURING FINAL TIGHTENING OF SET SCREW. TLIF INSERTERS BENT FROM OVER TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139733 ↗
• MalfunctionApr 18, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON MARCH 1, 2024 THE DRIVERS STRIPPED DURING FINAL TIGHTENING OF SET SCREW. TLIF INSERTERS BENT FROM OVER TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 4 OF 6 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139725 ↗
• MalfunctionMar 14, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THE DEVICE ARRIVED AT THE WAREHOUSE BROKEN INSIDE THE SET. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE IMPLANT INSERTER SH CONNECTION FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18904579 ↗
• MalfunctionFeb 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON SEPTEMBER 1, 2023, THAT THE ITEM IS PART OF AN ORTHOKIT LOAN AND WAS ON LOAN, SO THAT THE CAGE ON THE SETTING INSTRUMENT DID NOT HOLD WELL AND LOOSENED UP. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM REPORTED 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 18668066 ↗
• MalfunctionFeb 1, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: IT WAS REPORTED THAT THERE WAS AN INSTRUMENT FAILURE FOR EQUIPMENT NO.: 500069097 CAGE CONDUIT, SH INSERTER BROKEN IMPLANT CONNECTION REF: TFT30101. INSERTER REMAINS INSIDE THE TAKER. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624444 ↗
• MalfunctionJan 26, 2024Material Deformation; Material Deformation

  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) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 2 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586984 ↗
• MalfunctionNov 24, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED ON OCTOBER 31, 2023, THAT THE TIP OF INSTRUMENT BENDED. THERE WAS NO DELAY DUE TO THE REPORTED EVENT. SURGERY WAS PERFORMED AS PLANNED. ANOTHER INSTRUMENT WAS USED. THERE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204539 ↗
• MalfunctionNov 22, 2023Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS ON NOVEMBER 1, 2023, THAT THE TIP OF THE INNERSHAFT WAS BENDED. NOT POSSIBLE TO LOAD IMPLANT. THE ISSUE WAS DISCOVERED BY OR STAFF DURING SURGERY. SURGERY WAS PERFORMED AS PLANNED WITH ANOTHER INSTRUMENT. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193924 ↗
• MalfunctionOct 23, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 WHILE INSERTING THE LAST SCREW IN S1, THE PATIENT¿S BONE DID NOT HOLD THE PLANNED SCREW AS INTENDED (NOT A GOOD BITE). THE SURGEON HAD TO REMOVE THE PLANNED (8X40MM SCREW) AND INSERT IN A (8X45MM) BI-CORTICALLY, THEN MADE SURE THAT THE OTHER S1 (8X40MM) SCREW WAS ALSO BI-CORTICAL. SURGEON WAS THEN HAPPY WITH BOTH SCREW POSITIONS. DISCARDED THE 8X40MM SCREW THAT WAS REMOVED. DURING THE CASE UPON INSERTING THE CAGE THE SURGEON WAS INSERTING THE L4/5 CAGE, THE INSERTER SHAFT DID NOT ENGAGE WELL, THE SURGEON REMOVED IT FROM THE PATIENT WITH CAGE STILL ATTACHED. UPON INSPECTION, THE T BAR WAS FOUND TO BE BENT AT THE TIP, AND THE THREAD WAS WORN OUT AT THE PROXIMAL END THAT ENGAGES INTO THE KNOB. ANOTHER INSERTER FROM THE SET WAS USED TO INSERT THE CAGE AT L4/5. THEN PROCEEDED TO INSERT L5/S1 CAGE USING THAT SECOND INSERTER. ONCE MALLETED INTO THE DISC SPACE AND THE SURGEON WAS HAPPY WITH THE POSITIONING, HE SURGEON WAS UNABLE TO REMOVE THE INSERTER FROM THE CAGE BY TURNING THE PROXIMAL KNOB AS USUAL. THE INNER SHAFT THEN BROKE WHERE THE PROXIMAL END OF THE INNER SHAFT IS STILL IN THE INSERTER.

  Patient problems: Insufficient Information

  MAUDE report 17985840 ↗
• MalfunctionOct 23, 2023Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 WHILE INSERTING THE LAST SCREW IN S1, THE PATIENT¿S BONE DID NOT HOLD THE PLANNED SCREW AS INTENDED (NOT A GOOD BITE). THE SURGEON HAD TO REMOVE THE PLANNED (8X40MM SCREW) AND INSERT IN A (8X45MM) BI-CORTICALLY, THEN MADE SURE THAT THE OTHER S1 (8X40MM) SCREW WAS ALSO BI-CORTICAL. SURGEON WAS THEN HAPPY WITH BOTH SCREW POSITIONS. DISCARDED THE 8X40MM SCREW THAT WAS REMOVED. DURING THE CASE UPON INSERTING THE CAGE THE SURGEON WAS INSERTING THE L4/5 CAGE, THE INSERTER SHAFT DID NOT ENGAGE WELL, THE SURGEON REMOVED IT FROM THE PATIENT WITH CAGE STILL ATTACHED. UPON INSPECTION, THE T BAR WAS FOUND TO BE BENT AT THE TIP, AND THE THREAD WAS WORN OUT AT THE PROXIMAL END THAT ENGAGES INTO THE KNOB. ANOTHER INSERTER FROM THE SET WAS USED TO INSERT THE CAGE AT L4/5. THEN PROCEEDED TO INSERT L5/S1 CAGE USING THAT SECOND INSERTER. ONCE MALLETED INTO THE DISC SPACE AND THE SURGEON WAS HAPPY WITH THE POSITIONING, HE SURGEON WAS UNABLE TO REMOVE THE INSERTER FROM THE CAGE BY TURNING THE PROXIMAL KNOB AS USUAL. THE INNER SHAFT THEN BROKE WHERE THE PROXIMAL END OF THE INNER SHAFT IS STILL IN THE INSERTER.

  Patient problems: Insufficient Information

  MAUDE report 17985838 ↗
• MalfunctionOct 11, 2023Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914821 ↗
• MalfunctionOct 6, 2023Break; Break

  THERE WAS NO PATIENT IMPACT, NO SURGICAL DELAY AND NO CHANGE IN SURGICAL METHOD. PRODUCT WAS DETECTED AS BROKEN DURING INSPECTION AT LOCAL DC.

  Patient problems: Insufficient Information

  MAUDE report 17885888 ↗
• MalfunctionSep 11, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED ON AUGUST 25, 2023, THAT THE CUSTOMER RECEIVED MODULE MSTLIF4N BUILD 8 ON (B)(6) 2023,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) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725494 ↗
• MalfunctionSep 11, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THE EVENT OCCURRED ON (B)(6), 2023. THE PATIENT STATUS WAS REPORTED TO BE OKAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720881 ↗
• InjuryAug 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD KNOWN BROKEN INSTRUMENT PARTICLE(TFT30101 C) IN THE PATIENT AFTER MRI FOLLOW UP. HE WANT TO KNOW INFLUENCE OF BROKEN INSTRUMENT. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17442384 ↗
• MalfunctionJul 6, 2023Break; Mechanical Jam; Break; Mechanical Jam

  THERE WAS SURGICAL DELAY OF 5- 10 MINUTES, UNTIL THE CONDUIT TLIF CAGE WAS NEWLY CLAMPED IN THE SECOND TLIF IMPLANT HOLDER AND READY FOR IMPLANTATION. THE DR. WAS ABLE TO COMPLETE THE SURGERY WITH THE SECOND CONDUIT TLIF IMPLANT HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269239 ↗

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-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
• 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