ALEUTIAN® Interbody Systems 702-90167Recalls & reported problems
VB Spine LLC · ALIF Trial Inserter · Class 2
All models of ALEUTIAN Interbody Systems (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857127890), received between Mar 8, 2022 and Jan 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Difficult to Remove1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2025Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21094369 ↗MalfunctionMar 8, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO ANTERIOR LUMBAR DISC PREP TRIAL INSERTERS ARRIVED BROKEN AT THE TIPS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13697420 ↗MalfunctionMar 8, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO ANTERIOR LUMBAR DISC PREP TRIAL INSERTERS ARRIVED BROKEN AT THE TIPS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13697394 ↗
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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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