EIT LLIF cage LUI81054Recalls & reported problems
EIT Emerging Implant Technologies GmbH · EIT LLIF, H 10mm, 8°, 55/18 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557834831), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THIS WAS A ATP (L3/4) FOR SPINAL CANAL STENOSIS ON (B)(6) 2025. DURING THE SURGERY, THE INSERTER AND THE HEX DRIVER WERE COMBINED AND USED AS AN IMPLANT INSERTER. AFTER PLACING THE IMPLANT CONDUIT IN THE CORRECT POSITION, THE HEX DRIVER WAS ROTATED IN THE REVERSE DIRECTION AS INSTRUCTED TO REMOVE IT, BUT THE CONDUIT DID NOT COME OUT. THE IMPLANT AND INSERTER WERE NOT STUCK TOGETHER BUT WERE LOOSE AND THE HEX DRIVER WAS ABLE TO MOVE. SUSPECTING AN ANGLE ISSUE, THE HEX DRIVER WAS PULLED UP WHILE SLIGHTLY CHANGING THE ANGLE IN VARIOUS DIRECTIONS, BUT IT DID NOT COME OUT. CONSIDERING THAT THE HEX DRIVER MIGHT NOT HAVE BEEN LOOSE ENOUGH, IT WAS ROTATED IN THE REVERSE DIRECTION AGAIN, BUT THE HEX DRIVER CAME OUT. AT THIS POINT, THE CONDUIT ALSO CAME OUT. THE HEX DRIVER WAS THEN REMOVED FROM THE BODY WITH THE CONDUIT STILL ATTACHED, AND WHEN IT WAS MOVED, THE CONDUIT CAME OUT. IT WAS THEN ATTACHED TO A DIFFERENT TYPE OF STRAIGHT INSERTER AND REINSERTED. THIS CAME OUT AS NORMAL, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017391 ↗
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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