DENALI® Spinal System 101-06545Recalls & reported problems
VB Spine LLC · Polyaxial Screw Size Ø6.5x45 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 10888857002777), received between Jul 22, 2020 and Jan 5, 2024 — 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
- Injury1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-OPERATIVELY A PATIENT WAS REVISED TO ADDRESS THE FRACTURE OF A DENALI POLYAXIAL SCREW.
Patient problems: Insufficient Information
MAUDE report 18460525 ↗InjuryJul 22, 2020Fracture; Fracture
THE PATIENT WAS REVISED FOR A DENALI SCREW, THAT FRACTURED AT THE HEAD OF THE TULIP AT THE L5/S1 LEVEL, AND A DISC COMPRESSION. THE PATIENT NOTED PAIN FROM THE DISC COMPRESSION, NOT FROM THE SCREW FRACTURE. THE PATIENT FUSED AND WAS REPORTED TO BE DOING "HEAVY MANUAL LABOR." A NEW SCREW WAS PLACED IN PARALLEL AT LEFT SIDE OF S1.
Patient problems: Injury; Pain
MAUDE report 10307940 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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