CASCADIA™ Interbody System 6101-2185012LL8-G2Recalls & reported problems
VB Spine LLC · 6101-2185012LL8-G2 · Class 2 · Implant
All models of CASCADIA Interbody System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857218277), received between Sep 30, 2021 and Sep 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TIP OF THE CAYMAN MI SPRING LOADED AWL BENT INTRA-OPERATIVELY. THE AWL IS USED TO PREPARE THE BONE FOR PLACEMENT OF SCREWS. THE SURGEON DID NOT ELECT TO USE OR DID NOT HAVE ON HAND A BACK-UP INSTRUMENT TO PREPARE THE SECOND SCREW HOLE. THE CAYMAN UNITED TWO-HOLE PLATE AND CASCADIA INTERBODY WERE IMPLANTED BUT ONLY ONE OF TWO SECURING SCREWS WAS PLACED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AND THE SURGEON DOES NOT PLAN TO RE-OPERATE AT THIS TIME. THIS RECORD CAPTURES THE CASCADIA INTERBODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12558235 ↗
Other Intervertebral fusion device with bone graft, cervical devices
- ROI-C MC1005TLDR Spine Usa, Inc. · Intervertebral Fusion Device With Bone Graft, Cervical54 reports
- EIT CIF cage CUI8070SEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall4 reports
- EIT CIF cage CUI8060LEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall1 report
- CONSTRUX - MINI Ti 37-7212SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-8015SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-7206SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-8007SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI PTC 37-4211SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 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