ALEUTIAN Interbody SystemsRecalls & reported problems across all models
VB Spine LLC · 37 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 135
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 37 models of ALEUTIAN Interbody Systems by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 135 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2015 and Sep 23, 2026 — classified as 5 injuries, 129 malfunctions.
The most frequently reported specific device problem is “Fracture” (85 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ALEUTIAN Interbody Systems problems
Device problems
- Fracture85
- Material Deformation37
- Mechanical Jam21
- Insufficient Device Problem Information5
- No Apparent Adverse Event5
- Failure to Eject4
- Mechanical Problem4
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions126
- No Consequences Or Impact To Patient4
- No Information4
- Pain2
- Injury1
- Not Applicable1
- Post Operative Wound Infection1
ALEUTIAN Interbody Systems models
37 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ALEUTIAN® Interbody Systems 3303-90152Intervertebral fusion device with bone graft, lumbar44 reports
- ALEUTIAN® Interbody Systems 602-90780Intervertebral fusion device with bone graft, lumbar14 reports
- ALEUTIAN® Interbody Systems 3303-90603Intervertebral fusion device with bone graft, lumbar11 reports
- ALEUTIAN® Interbody Systems 602-90776Intervertebral fusion device with bone graft, lumbar7 reports
- ALEUTIAN® Interbody Systems 3201-90293Orthopedic manual surgical instrument4 reports
- ALEUTIAN® Interbody Systems 3303-90384Intervertebral fusion device with bone graft, lumbar4 reports
- ALEUTIAN Interbody Systems 5303-90004Orthopedic manual surgical instrument4 reports
- ALEUTIAN® Interbody Systems 602-90449SPINAL VERTEBRAL BODY REPLACEMENT DEVICE4 reports
- ALEUTIAN® Interbody Systems 3303-90151Intervertebral fusion device with bone graft, lumbar3 reports
- ALEUTIAN Interbody Systems 5303-90001Orthopedic manual surgical instrument3 reports
- ALEUTIAN Interbody Systems 602-90254Orthopedic manual surgical instrument3 reports
- ALEUTIAN® Interbody Systems 702-90167Intervertebral fusion device with bone graft, cervical3 reports
- ALEUTIAN® Interbody Systems SP-3140Intervertebral fusion device with bone graft, cervical3 reports
- ALEUTIAN Interbody Systems 5203-90100Orthopedic manual surgical instrument2 reports
- ALEUTIAN Interbody Systems 5203-90101Orthopedic manual surgical instrument2 reports
- ALEUTIAN Interbody Systems 5303-90002Orthopedic manual surgical instrument2 reports
- ALEUTIAN® Interbody Systems 602-90448Intervertebral fusion device with bone graft, cervical2 reports
- ALEUTIAN® Interbody Systems 3201-90270SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- ALEUTIAN® Interbody Systems 3203-21055SLIntervertebral fusion device with bone graft, cervical1 report
- ALEUTIAN® Interbody Systems 3303-20728MIntervertebral fusion device with bone graft, lumbar1 report
- ALEUTIAN® Interbody Systems 3303-21028MSPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- ALEUTIAN® Interbody Systems 3303-21128MIntervertebral fusion device with bone graft, cervical1 report
- ALEUTIAN Interbody Systems 3303-90078Orthopedic manual surgical instrument1 report
- ALEUTIAN® Interbody Systems 403-22007PSPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- ALEUTIAN® Interbody Systems 4708-21432MT5SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- ALEUTIAN® Interbody Systems 5203-20428L6Intervertebral fusion device with bone graft, lumbar1 report
- ALEUTIAN Interbody Systems 5203-90109Orthopedic manual surgical instrument1 report
- ALEUTIAN Interbody Systems 5203-90167Orthopedic manual surgical instrument1 report
- ALEUTIAN Interbody Systems 602-90257Orthopedic manual surgical instrument1 report
- ALEUTIAN Interbody Systems 602-90259Orthopedic manual surgical instrument1 report
- ALEUTIAN® Interbody Systems 602-90367Intervertebral fusion device with bone graft, cervical1 report
- ALEUTIAN® Interbody Systems 602-90777Intervertebral fusion device with bone graft, lumbar1 report
- ALEUTIAN® Interbody Systems 603-20722PBSPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- ALEUTIAN® Interbody Systems 603-20728CIntervertebral fusion device with bone graft, lumbar1 report
- ALEUTIAN® Interbody Systems 603-20822CSPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- ALEUTIAN® Interbody Systems 702-90178Intervertebral fusion device with bone graft, cervical1 report
- ALEUTIAN® Interbody Systems 702-90369Intervertebral fusion device with bone graft, cervical1 report
Recent ALEUTIAN Interbody Systems adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fracture; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874005 ↗MalfunctionJul 14, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25820822 ↗MalfunctionJun 9, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN AN INSERTER INNER SHAFT FRACTURED OFF INTRA-OPERATIVELY. 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 25448052 ↗MalfunctionApr 9, 2026Device Reprocessing Problem; Contamination
IT WAS REPORTED THAT AN ALEUTIAN TLIF II STRAIGHT INSERTER WAS OBSERVED TO CONTAIN FOREIGN RESIDUE INTRA-OPERATIVELY. THE DEVICE WAS THEN RE-STERILIZED AND CLEANED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 60 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836057 ↗MalfunctionApr 7, 2026Fracture
IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY DURING CAGE INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811918 ↗MalfunctionMar 5, 2026Fracture
A CUSTOMER REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521620 ↗MalfunctionMar 5, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED COMPONENT REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519206 ↗MalfunctionMar 4, 2026Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506734 ↗MalfunctionMar 3, 2026Fracture; Material Deformation; Mechanical Jam
A COMPANY REPRESENTATIVE REPORTED THAT AN ALEUTIAN TLIF II ADJUSTABLE INSERTER WAS DIFFICULT TO DISASSEMBLE FROM A CAGE AND THAT AN ALEUTIAN TLIF II ADJUSTABLE INSERTER INNER SHAFT WAS "BROKEN" INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503623 ↗MalfunctionJan 27, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN ALEUTIAN AN INSERTER AND AN ALEUTIAN AN INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY AND THAT A DEVICE COMPONENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE ALEUTIAN AN MI INSERTER INNER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189801 ↗MalfunctionJan 27, 2026Fracture; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT AN ALEUTIAN AN INSERTER AND AN ALEUTIAN AN INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY AND THAT A DEVICE COMPONENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE ALEUTIAN AN MI INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189795 ↗MalfunctionJan 21, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136017 ↗MalfunctionDec 19, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854802 ↗MalfunctionDec 14, 2025Fracture; Fracture
A HEALTH PROFESSIONAL REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799737 ↗MalfunctionOct 17, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO ALEUTIAN AN INSERTERS FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23330820 ↗
Other VB Spine LLC products
- EVEREST Spinal System77 models · 336 reports · 3 recalls
- YUKON OCT Spinal System54 models · 238 reports · 3 recalls
- OZARK Cervical Plate System54 models · 270 reports
- MESA Spinal System55 models · 140 reports
- CHESAPEAKE Stabilization System31 models · 46 reports · 1 recall
- PYRENEES Cervical Plate System29 models · 96 reports
- DENALI Spinal System22 models · 80 reports
- CASCADIA Interbody System28 models · 65 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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