EIT TLIF cage TUI31032Recalls & reported problems
EIT Emerging Implant Technologies GmbH · EIT TLIF, H 10mm, 12°, 32/12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260557776797), received between May 22, 2025 and May 22, 2025 — classified as 2 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
STUDY NO: (B)(4). SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DUROTOMY: SEVERITY: MILD, IS THE ADVERSE EVENT SERIOUS? NO, RELATIONSHIP TO STUDY DEVICE: NOT RELATED RELATIONSHIP TO PRIMARY STUDY PROCEDURE: NOT RELATED, OUTCOME: RECOVERED/RESOLVED, DATE OF EVENT: 21 SEP 2022, DATE OF IMPLANT: ON (B)(6) 2022, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: L2-L3, L3-L4, L4-L5. TREATMENT/IMPACT: SURGICAL INTERVENTION NOT FOR THE STUDY SPINE SEGMENT, SPECIFY: L3 TREATED WITH MUSCLE PLUG AND TISSEEL L3-4 TREATED WITH 6-0 GORE-TEX AND MUSCLE PLUG, TISSEEL. DATE OF SURGICAL INTERVENTION: ON (B)(6) 2022.
Patient problems: Unspecified Tissue Injury
MAUDE report 22070419 ↗InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR BLOOD LOSS. TYPE OF EVENT: SYSTEMIC. SEVERITY: MODERATE. IS THE ADVERSE EVENT SERIOUS? NO. RELATIONSHIP TO STUDY DEVICE: NOT RELATED RELATIONSHIP TO PRIMARY STUDY PROCEDURE: NOT RELATED. OUTCOME: RECOVERED/RESOLVED. DATE OF EVENT: 21 SEP 2022. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: L2-L3, L3-L4. TREATMENT/IMPACT: BLOOD TRANSFUSION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22069378 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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