DENALI® Spinal System 101-65545Recalls & reported problems
VB Spine LLC · 101-65545 · Class 2 · Implant
All models of DENALI Spinal System (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857006720), received between Aug 22, 2018 and Dec 3, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (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
- Migration2
- Fracture1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED EVEREST SET SCREWS AND TWO MIGRATED DENALI CONTOURED RODS. THIS REPORT CAPTURES THE SECOND OF TWO RODS.
Patient problems: Insufficient Information
MAUDE report 23706637 ↗InjuryDec 3, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED EVEREST SET SCREWS AND TWO MIGRATED DENALI CONTOURED RODS. THIS REPORT CAPTURES THE FIRST OF TWO RODS.
Patient problems: Insufficient Information
MAUDE report 23706632 ↗InjuryAug 22, 2018Fracture; Fracture
THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST. REPORT WAS INITIALLY REPORTED AS 3004774118-2018-00134. IT WAS REPORTED THAT A PATIENT PRESENTED WITH ROD SLIPPED OUT OF A POLYAXIAL SCREW APPROXIMATELY 3 MONTHS POST-OPERATIVELY. REVISION SURGERY TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 7805264 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
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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.
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