ALEUTIAN® Interbody Systems 3303-90152Recalls & reported problems
VB Spine LLC · Straight Inserter, Inner Shaft, Size Inner Shaft · Class 2
All models of ALEUTIAN Interbody Systems (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the VB Spine Aleutian straight inserter inner shaft, a surgical instrument used to place bone graft cages in the lower spine during fusion. The 45 reports mostly describe the tip of the shaft snapping off during surgery, in some cases leaving the broken piece in the patient; a few mention bending, jamming or the part not releasing. There are no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10888857076617), received between Nov 10, 2021 and Apr 7, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Fracture” (39 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
- Fracture39
- Material Deformation7
- Difficult to Insert1
- Failure to Eject1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
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 ↗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 10, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23267239 ↗MalfunctionOct 10, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23267236 ↗MalfunctionJul 31, 2025Material Deformation; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676493 ↗MalfunctionJul 31, 2025Material Deformation; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676491 ↗MalfunctionJun 18, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam
IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY AND REMAINS IN THE PATIENT. 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 22284521 ↗MalfunctionJun 13, 2025Fracture; Fracture
IT WAS 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 22205307 ↗MalfunctionJun 10, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22180096 ↗MalfunctionJun 6, 2025Fracture; Material Deformation; Fracture; Material Deformation
A COMPANY REPRESENTATIVE 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 22161993 ↗MalfunctionMay 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED OFF INTRA-OPERATIVELY DURING CAGE INSERTION. 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 21979019 ↗MalfunctionApr 30, 2025Fracture; Material Deformation; Fracture; Material Deformation
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 21938172 ↗MalfunctionApr 17, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860240 ↗MalfunctionFeb 19, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21417357 ↗MalfunctionFeb 19, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21417356 ↗MalfunctionJan 15, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED 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 21161780 ↗MalfunctionNov 13, 2024Fracture; Fracture
IT WAS 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 20675265 ↗MalfunctionSep 5, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY AND THAT THE TIP REMAINED IN THE IMPLANTED CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20153719 ↗MalfunctionJul 16, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN 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 19756845 ↗MalfunctionJul 8, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN 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 19694904 ↗MalfunctionJul 2, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN STRAIGHT INSERTER INNER SHAFT FRACTURED OFF INTRA-OPERATIVELY, AND THAT THE TIP REMAINED IN THE IMPLANTED CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19660563 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page