EIT TLIF Trial TFT81328Recalls & reported problems
EIT Emerging Implant Technologies GmbH · Trial, H 13mm, 8°, 28/10 · Class 2
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 04260557775158), received between Feb 25, 2022 and Feb 25, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
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.
MalfunctionFeb 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TRIAL IMPLANT COULD NOT BE CONNECTED TO THE TRIAL IMPLANT HOLDER. ALL OTHER TRIAL IMPLANTS COULD BE CONNECTED TO THE TRIAL IMPLANT HOLDER WITHOUT ANY ISSUE. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) TRIAL, H 13MM, 8, 28/10. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13603630 ↗
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 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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