EIT LLIF InserterRecalls & reported problems across all models
EIT Emerging Implant Technologies GmbH · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of EIT LLIF Inserter by EIT Emerging Implant Technologies GmbH in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Sep 9, 2020 and Nov 17, 2025 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (37 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 LLIF Inserter problems
Device problems
- Device-Device Incompatibility37
- Break14
- Mechanical Jam11
- Material Deformation7
- Material Twisted/Bent4
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- Insufficient Information9
- No Consequences Or Impact To Patient3
- Foreign Body In Patient1
EIT LLIF Inserter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EIT LLIF Inserter LET20100Intervertebral Fusion Device With Bone Graft, Lumbar36 reports
- EIT LLIF Inserter LET30100Intervertebral Fusion Device With Bone Graft, Lumbar24 reports
Recent EIT LLIF Inserter adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionAug 6, 2024Break; Break
IT WAS REPORTED THE CONDUIT LLIF INSERTER BROKE INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED AS DOING REALLY WELL. THIS REPORT IS FOR A CONDUIT LLIF INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917880 ↗MalfunctionAug 1, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE HAS BEEN NO REMOVAL/ REVISION SURGERY AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 19882822 ↗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 ↗MalfunctionFeb 15, 2024Break; Entrapment of Device; Break; Entrapment of Device
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON AN ATP PROCEDURE WITH LLIF CONDUIT DURING THE INSERTION OF THE CAGE THE ANTI-ROTATION PART OF INNER SHAFT OF THE INSERTER WAS BROKEN. DURING THE IMPLANTATION OF THE CAGE THIS METAL PART OF THE INSTRUMENT DISAPPEARED BETWEEN THE ENDPLATE AND THE CAGE INTO THE DISC SPACE L3-4. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 18711219 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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