DENALI Spinal SystemRecalls & reported problems across all models
VB Spine LLC · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 22 models of DENALI Spinal System by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2015 and Jan 13, 2026 — classified as 48 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Fracture” (37 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DENALI Spinal System problems
Device problems
- Fracture37
- Migration19
- Material Deformation13
- Migration or Expulsion of Device11
- Device Dislodged or Dislocated5
- Break4
- Adverse Event Without Identified Device or Use Problem2
- Improper or Incorrect Procedure or Method2
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Information15
- Injury11
- Insufficient Information7
- Pain7
- No Consequences Or Impact To Patient6
- No Code Available5
- No Known Impact Or Consequence To Patient2
DENALI Spinal System models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DENALI® Spinal System 101-10001Orthosis, spondylolisthesis spinal fixation24 reports
- DENALI Spinal System 101-90101Orthopedic manual surgical instrument7 reports
- DENALI Spinal System 101-90208Orthopedic manual surgical instrument6 reports
- DENALI® Spinal System 101-A55500Pedicle screw spinal system, adolescent idiopathic scoliosis6 reports
- DENALI® Spinal System 111-B55500APPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- DENALI Spinal System 101-90054Orthopedic manual surgical instrument5 reports
- DENALI® Spinal System 101-06535Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- DENALI® Spinal System 101-65545Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- DENALI Spinal System 101-90295Orthopedic manual surgical instrument3 reports
- DENALI® Spinal System 101-06545APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- DENALI® Spinal System 101-06565APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- DENALI Spinal System 101-90317Orthopedic manual surgical instrument2 reports
- DENALI® Spinal System 111-B655375ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- DENALI® Spinal System 101-05545ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- DENALI® Spinal System 101-08580APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- DENALI® Spinal System 101-555100Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- DENALI® Spinal System 101-555500APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- DENALI® Spinal System 101-65560Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- DENALI® Spinal System 101-65590APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- DENALI Spinal System 101-90197Orthopedic manual surgical instrument1 report
- DENALI® Spinal System SP-716ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- DENALI® Spinal System 101-555500-G1Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
Recent DENALI Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 13, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO DENALI STRAIGHT DEFORMITY RODS THAT MIGRATED APPROXIMATELY FIVE MONTHS POST-OPERATIVELY. THIS REPORT CAPTURES THE FIRST OF TWO RODS.
Patient problems: Insufficient Information
MAUDE report 24064057 ↗InjuryJan 13, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO DENALI STRAIGHT DEFORMITY RODS THAT MIGRATED APPROXIMATELY FIVE MONTHS POST-OPERATIVELY. THIS REPORT CAPTURES THE SECOND OF TWO RODS.
Patient problems: Insufficient Information
MAUDE report 24064056 ↗MalfunctionDec 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CUSTOMER REPORTED THAT THE PIN OF A DENALI SCREW BASED DISTRACTOR DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PIN WAS UNABLE TO BE LOCATED IN THE ROOM OR IN AN X-RAY OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799747 ↗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 ↗InjuryNov 25, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY TO ADDRESS ONE MIGRATED XIA 3 TITANIUM BLOCKER AND ONE MIGRATED DENALI STRAIGHT DEFORMITY ROD. THIS REPORT CAPTURES THE ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647505 ↗InjurySep 23, 2025Fracture; Fracture
A CUSTOMER REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A FRACTURED DENALI CONTOURED ROD AND A MIGRATED UNKNOWN CAGE. THE PATIENT REPORTED EXPERIENCING PAIN. THIS REPORT CAPTURES THE DENALI ROD.
Patient problems: Pain
MAUDE report 23124962 ↗InjuryApr 2, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 3.5 MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED DENALI CONTOURED DEFORMITY RODS. THIS REPORT CAPTURES THE FIRST OF TWO RODS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21758948 ↗InjuryApr 2, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 3.5 MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED DENALI CONTOURED DEFORMITY RODS. THIS REPORT CAPTURES THE SECOND OF TWO RODS.
Patient problems: Insufficient Information
MAUDE report 21758890 ↗InjuryFeb 2, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS THE MIGRATION OF AN AVIATOR VARIABLE SELF-DRILLING SCREW AT LEFT-SIDE C7. DURING SURGERY, IT WAS DISCOVERED THAT THE LOCKING WING OF THE AVIATOR THREE-LEVEL PLATE WAS FRACTURED AT THAT SAME LEVEL. THIS REPORT CAPTURES THE AVIATOR VARIABLE SELF-DRILLING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18630964 ↗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 ↗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 ↗InjuryJan 27, 2023Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS POST-OPERATIVELY A DENALI STRAIGHT ROD FRACTURED. REVISION SURGERY WAS PERFORMED AND THE ROD WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16259726 ↗InjuryOct 13, 2022Migration; Migration
A PHYSICIAN REPORTED THAT A PATIENT HAS LOST CORRECTION APPROXIMATELY SIX-YEAR POST-IMPLANTATION. THE PATIENT HAS EXPERIENCED KYPHOSIS AND, "THE HOOKS CUT OUT OF THE PATIENT'S BACK AT THE TOP," LEAVING THE PATIENT WITH TWO OPEN WOUNDS IN THE THORACIC AREA WHERE THE RODS ARE PENETRATING THE SKIN. THE PHYSICIAN REPORTS THAT THE CONSTRUCT IS STILL INTACT BUT NOT ATTACHED TO THE BONE (THE SCREWS HAVE MIGRATED); REVISION SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS IMPLANTED WITH DENALI RODS, MESA HOOKS, AND MESA PEDICLE SCREWS. THIS REPORT CAPTURES THE SECOND OF TWO MESA HOOKS.
Patient problems: Tissue Breakdown
MAUDE report 15601430 ↗
Other VB Spine LLC products
- EVEREST Spinal System77 models · 336 reports · 3 recalls
- YUKON OCT Spinal System54 models · 238 reports · 3 recalls
- OZARK Cervical Plate System54 models · 270 reports
- MESA Spinal System55 models · 140 reports
- ALEUTIAN Interbody Systems37 models · 135 reports
- CHESAPEAKE Stabilization System31 models · 46 reports · 1 recall
- PYRENEES Cervical Plate System29 models · 96 reports
- CASCADIA Interbody System28 models · 65 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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