EIT TLIF InserterRecalls & reported problems across all models
EIT Emerging Implant Technologies GmbH · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 140
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 4 models of EIT TLIF Inserter by EIT Emerging Implant Technologies GmbH in the FDA's device registry (GUDID). Together they are named in 140 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2019 and Sep 23, 2026 — classified as 11 injuries, 129 malfunctions.
The most frequently reported specific device problem is “Break” (56 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EIT TLIF Inserter problems
Device problems
- Break56
- Device-Device Incompatibility52
- Material Deformation22
- Material Twisted/Bent10
- Appropriate Device Problem Term/Code Not Available7
- Detachment of Device or Device Component5
- Entrapment of Device5
- Device Slipped4
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- No Consequences Or Impact To Patient14
- No Code Available10
- Insufficient Information7
- No Known Impact Or Consequence To Patient7
- Tissue Damage7
- Foreign Body In Patient5
- Injury2
EIT TLIF Inserter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EIT TLIF Inserter TFT30101Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- EIT TLIF Inserter TFT20101Intervertebral Fusion Device With Bone Graft, Lumbar49 reports
- EIT TLIF Inserter TFT20100Intervertebral Fusion Device With Bone Graft, Lumbar2 reports
- EIT TLIF Inserter TFT30100Intervertebral Fusion Device With Bone Graft, Lumbar1 report
Recent EIT TLIF Inserter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
Patient problems: Insufficient Information
MAUDE report 50872990 ↗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 21152335 ↗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 ↗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 ↗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 ↗
Other EIT Emerging Implant Technologies GmbH products
All EIT Emerging Implant Technologies GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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