DENALI® Spinal System 101-06535Recalls & reported problems
VB Spine LLC · Polyaxial Screw Size Ø6.5x35 mm · Class 2 · Implant
All models of DENALI Spinal System (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857002715), received between Jan 28, 2020 and Jun 17, 2020 — classified as 2 injuries, 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Fracture2
- Material Deformation1
Patient problems
- Injury2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT A DENALI POLYAXIAL SCREW AND TWO UNKNOWN SCREWDRIVER TIPS DEFORMED INTRA-OPERATIVELY. DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE SCREW PLACED AT S1 WAS SHORT IN LENGTH. HE DECIDED TO CHANGE IT FOR A LONGER ONE, BUT COULD NOT REMOVE IT BECAUSE THE SCREW WAS BENT AND THE SCREWDRIVERS WERE ROLLED. THE SURGEON REMOVED BONE FROM THE VERTEBRA AND MANDRELS WERE USED TO REMOVE THE SCREW. THIS REPORT REPRESENTS THE SCREW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10163303 ↗InjuryJan 28, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO DENALI POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT REPRESENTS THE 1ST OF THE 2 SCREWS.
Patient problems: Injury
MAUDE report 9638177 ↗InjuryJan 28, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO DENALI POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT REPRESENTS THE 2ND OF THE 2 SCREWS.
Patient problems: Injury
MAUDE report 9636547 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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