EIT PLIF cage PUI41106Recalls & reported problems
EIT Emerging Implant Technologies GmbH · EIT PLIF, H 11mm, 4°, 26/9 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557778524), received between Nov 12, 2021 and Nov 12, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2021Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2021 A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SPACER WAS IMPLANTED IN THE PATIENT¿S L4/L5 SPINAL SEGMENT. ON AN UNKNOWN DATE THE IMPLANT SUBLUXED POSTERIORLY AND OBLIQUELY TO THE PATIENTS LEFT APPROXIMATELY 10-15MM. THE PATIENT WAS EXPERIENCING PAIN IN THEIR LEFT LEG BUT NO ASSOCIATED WEAKNESS. UPON REVIEWING AN X-RAY OF THE PATIENT¿S LUMBAR SPINE THE MALPOSITIONED SPACER WAS DISCOVERED. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2021 TO REPOSITION THE IMPLANT IN BETWEEN THE PATIENT¿S L4/5 VERTEBRAL SPACE. THE SURGEON WAS ABLE TO REACH THE SPACER WITH A LESS INVASIVE TUBULAR APPROACH AND IMPACT THE IMPLANT ANTERIORLY IN A MORE OPTIMAL POSITION. THE PATIENT IS COMFORTABLE AND DOING WELL. THIS REPORT IS FOR ONE (1) EIT PLIF, H 11MM, 4°, 26/9. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Pain
MAUDE report 12805008 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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