DENALI® Spinal System 101-06565Recalls & reported problems
VB Spine LLC · Polyaxial Screw Size Ø6.5x65 mm · Class 2 · Implant
All models of DENALI Spinal System (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857002890), received between Nov 9, 2023 and Nov 9, 2023 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2023Fracture; Fracture
A PATIENT REPORTED POST-OPERATIVE PAIN AND WAS REVISED. DURING REVISION, THE SURGEON OBSERVED THAT TWO DENALI POLYAXIAL SCREWS WERE FRACTURED. THE DEVICES WERE EXPLANTED AND THE TIPS OF THE SCREWS REMAIN IN THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO FRACTURED SCREWS.
Patient problems: Pain
MAUDE report 18107015 ↗InjuryNov 9, 2023Fracture; Fracture
A PATIENT REPORTED POST-OPERATIVE PAIN AND WAS REVISED. DURING REVISION, THE SURGEON OBSERVED THAT TWO DENALI POLYAXIAL SCREWS WERE FRACTURED. THE DEVICES WERE EXPLANTED AND THE TIPS OF THE SCREWS REMAIN IN THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO FRACTURED SCREWS.
Patient problems: Pain
MAUDE report 18107014 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 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 16, 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