EIT PLIF cage PUI91206Recalls & reported problems
EIT Emerging Implant Technologies GmbH · EIT PLIF, H 12mm, 18°, 26/9 · Class 2 · Implant
- 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 04260557821169), received between Oct 29, 2024 and Oct 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionOct 29, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 DURING A TLIF THE SURGEON TRIED TO TWIST A CONDUIT 12MM HT CAGE AND FELT A CRUNCH. IT WAS DISCOVERED THROUGH X-RAY THAT THE IMPLANT BROKE. THE DAMAGED IMPLANT AND ALL PIECES WERE REMOVED AND A NEW CAGE WAS PLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 20 MINUTES. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THE X RAY WAS TAKEN TO CONFIRM THAT ALL THE PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20557661 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.