ALEUTIAN Interbody Systems 5303-90001Recalls & reported problems
VB Spine LLC · AN Lordotic - Oblique Inserter Size 8.5x28 mm · Class 1
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 10888857110458), received between Jun 14, 2022 and Jul 7, 2022 — 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.
Most reported problems
Device problems
- Fracture2
- Material Deformation1
- 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.
MalfunctionJul 7, 2022Material Deformation; Material Deformation
A PHYSICIAN REPORTED THAT THE TONGS (TIP) OF AN ALEUTIAN AN CORONAL INSERTER BECAME DEFORMED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14950358 ↗MalfunctionJul 6, 2022Fracture; Mechanical Jam; Fracture; Mechanical Jam
IT WAS REPORTED THAT DURING SET REASSEMBLY OUTSIDE THE OR, THE KNOB OF AN ALEUTIAN AN CORONAL INSERTER OUTER SHAFT/HANDLE AND INSERTER WAS JAMMED. THERE WAS NO ASSOCIATED PROCEDURE WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS WERE SEEN. THIS REPORT CAPTURES THE INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14932829 ↗MalfunctionJun 14, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN AN CORONAL INSERTER WAS FRACTURED AND THE OUTER SHAFT/HANDLE WAS BROKEN OUTSIDE THE OR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691339 ↗
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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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