CASCADIA™ Interbody System 6101-90167Recalls & reported problems
VB Spine LLC · 6101-90167 · Class 2
All models of CASCADIA Interbody System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cascadia lumbar interbody fusion system is used with bone graft during spinal fusion surgery. The 25 reports mostly describe inserter tips breaking during surgery, sometimes making the instrument difficult to remove and causing short procedural delays; no deaths or injuries were reported. No recalls name this device. Reports rose from 8 in the previous period to 14 in the latest period.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888857270107), received between Oct 23, 2018 and Sep 21, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Fracture” (23 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
- Fracture23
- Difficult to Remove2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849148 ↗MalfunctionAug 7, 2026Fracture; Difficult to Remove
A health professional reported that the tip of a Cascadia AN Lordotic-Oblique Inserter fractured intra-operatively and was difficult to disassemble from an interbody. The procedure was completed successfully with a 15 minute surgical delay. No adverse consequences were reported. Inspection of additional returned products indicates that the tip of a second Cascadia Lordotic Oblique Inserter fractured and was difficult to disassemble from an interbody, and that the threading of one Cascadia Lordotic-Oblique Interbody was deformed. This report captures the second fractured Inserter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182169 ↗MalfunctionJun 25, 2026Fracture; Difficult to Remove
A HEALTH PROFESSIONAL REPORTED THAT THE TIP OF A CASCADIA AN LORDOTIC-OBLIQUE INSERTER FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630912 ↗MalfunctionJun 24, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CASCADIA AN LORDOTIC-OBLIQUE INSERTER FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25615620 ↗MalfunctionMay 20, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO CASCADIA AN LORDOTIC-OBLIQUE INSERTERS FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233698 ↗MalfunctionMay 20, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO CASCADIA AN LORDOTIC-OBLIQUE INSERTERS FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO 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 25233686 ↗MalfunctionMar 19, 2026Fracture
IT WAS REPORTED THAT THE TIP OF A CASCADIA LORDOTIC OBLIQUE INSERTER FRACTURED OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 1-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643732 ↗MalfunctionFeb 16, 2026Fracture
IT WAS REPORTED THAT ONE OF THE LATERAL PRONGS FROM TWO CASCADIA LORDOTIC OBLIQUE INSERTERS FRACTURED OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO CASCADIA LORDOTIC OBLIQUE INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24348450 ↗MalfunctionJan 27, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CASCADIA AN LORDOTIC-OBLIQUE INSERTER FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188924 ↗MalfunctionDec 17, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO CASCADIA AN LORDOTIC-OBLIQUE INSERTERS FRACTURED OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO CASCADIA AN LORDOTIC-OBLIQUE INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827585 ↗MalfunctionDec 17, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO CASCADIA AN LORDOTIC-OBLIQUE INSERTERS FRACTURED OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO CASCADIA AN LORDOTIC-OBLIQUE INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827572 ↗MalfunctionDec 5, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735723 ↗MalfunctionNov 18, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23588789 ↗MalfunctionOct 29, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CASCADIA AN LORDOTIC-OBLIQUE INSERTER FRACTURED OFF 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 23418398 ↗MalfunctionSep 23, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23129497 ↗MalfunctionJun 7, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CASCADIA AN LORDOTIC-OBLIQUE INSERTER FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT DEVICE WITH A ONE MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22163085 ↗MalfunctionMay 2, 2025Material Deformation; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951430 ↗MalfunctionMar 20, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21653544 ↗MalfunctionMar 14, 2025Fracture; Fracture
IT WAS REPORTED THAT THE LATERAL PRONGS OF TWO CASCADIA LORDOTIC OBLIQUE INSERTERS AND THE THREADING OF AN ALEUTIAN INSERTER INNER SHAFT FRACTURED DURING CAGE INSERTION. THE SURGEON THEN SWITCHED FROM AN OBLIQUE TLIF CAGE TO A PLIF CAGE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF THE TWO CASCADIA LORDOTIC OBLIQUE INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605972 ↗MalfunctionMar 14, 2025Fracture; Fracture
IT WAS REPORTED THAT THE LATERAL PRONGS OF TWO CASCADIA LORDOTIC OBLIQUE INSERTERS AND THE THREADING OF AN ALEUTIAN INSERTER INNER SHAFT FRACTURED DURING CAGE INSERTION. THE SURGEON THEN SWITCHED FROM AN OBLIQUE TLIF CAGE TO A PLIF CAGE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF THE TWO CASCADIA LORDOTIC OBLIQUE INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605971 ↗MalfunctionNov 19, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CASCADIA AN LORDOTIC OBLIQUE INSERTER FRACTURED 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 20718570 ↗MalfunctionJan 5, 2022Fracture; Fracture
IT WAS REPORTED THAT A CASCADIA AN INSERTER AND INNER SHAFT BROKE AT THE TIP INTRA-OPERATIVELY. 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 13170602 ↗MalfunctionDec 1, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A CASCADIA AN LORDOTIC INSERTER FRACTURED DURING CAGE ROTATION INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12908821 ↗MalfunctionOct 23, 2018Fracture; Fracture
THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST. IT WAS REPORTED THAT A SURGERY TOOK PLACE IN WHICH A SHAFT FROM AN OBLIQUE INSERTER BROKE INTRAOPERATIVELY. A PIECE OF THE SHAFT OF THE OBLIQUE INSERTER REMAINS IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 7997336 ↗
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.
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