EIT TLIF Trial TFT81228Recalls & reported problems
EIT Emerging Implant Technologies GmbH · Trial, H 12mm, L 28mm, W 10mm, 8° · Class 2
- 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 04260557775141), received between Aug 4, 2025 and Aug 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K170503); they may or may not involve this specific model.
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
- Device-Device Incompatibility1
- Material Twisted/Bent1
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.
MalfunctionAug 4, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE INSERTER PRODUCTS ARE WORN DUE TO FREQUENT USE AND NEED REPLACEMENT. THE HAMMER BROKE AND HAS A CRACK LINE. THE INSERTER KNOB HAS CORRODED THREADS AND IT IS NOT POSSIBLE TO FIT INTO THE OUTER SHAFT. THE TRIAL IS THE OLD REFERENCE SO IT DOESN¿T ALLOW CONNECTION WITH THE NEW OUTER AND INNER SHAFTS. ANOTHER TRIAL WAS WORN OUT AND ROTATED RELATIVE TO THE OUTER SHAFT WHILE IT WAS COMPLETELY CLOSED. THERE WAS NO PATIENT CONSEQUENCE. ISSUES WERE NOTED PREOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22700945 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.
- Z-1323-2022 · May 20, 2022 · Open, ClassifiedEIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
- Z-1324-2022 · May 20, 2022 · Open, ClassifiedEIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.