EIT TLIF cage TUI81428Recalls & reported problems
EIT Emerging Implant Technologies GmbH · EIT TLIF, H 14mm, 8°, 28/10 · 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 04260557776469), received between Jun 15, 2026 and Jun 15, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Dural Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INCIDENTAL DUROTOMY REPAIRED DURING PROCEDURE DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 19 MAY 2026, DATE OF IMPLANT: ON (B)(6) 2026, DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: L4-L5: YES. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE STUDY SPINE SEGMENT (ON (B)(6) 2026), DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: TUI81428, LOT NUMBER: NO INFORMATION PROVIDED, COMPONENT TYPE: CAGE, DESCRIPTION: EIT TLIF, H 14MM, 8°, 28/10, CATALOG NUMBER: UNK - SCREWS, LOT NUMBER: NO INFORMATION PROVIDED, COMPONENT TYPE: PEDICLE SCREWS, DESCRIPTION: EXPEDIUM VERSE(R) SPINAL SYSTEM PEDICLE SCREWS, CATALOG NUMBER: UNK - RODS, LOT NUMBER: NO INFORMATION PROVIDED, COMPONENT TYPE: RODS, DESCRIPTION: EXPEDIUM VERSE(R) SPINAL SYSTEM RODS.
Patient problems: Dural Tear
MAUDE report 25505810 ↗
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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