DENALI® Spinal System 101-10001Recalls & reported problems
VB Spine LLC · Set Screw ATR™ · Class 2 · Implant
All models of DENALI Spinal System (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DENALI spinal set screw is a small implant used in spinal fixation. Reports mostly describe screws loosening or moving out of place after surgery, often requiring repeat surgery to remove them and sometimes mentioning pain. There are 24 reports that name its identifier, mentioning 21 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888857003842), received between Sep 29, 2015 and Jun 22, 2021 — classified as 21 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Migration” (11 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.
Most reported problems
Device problems
- Migration11
- Migration or Expulsion of Device10
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem2
- Device Slipped1
Patient problems
- No Information11
- No Clinical Signs, Symptoms or Conditions7
- Injury5
- No Code Available4
- Pain2
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2021Migration; Migration
IT WAS REPORTED VIA XRAY THAT 3 DENALI SET SCREWS LOOSENED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTS WERE EXPLANTED. THIS REPORT CAPTURES THE FIRST OF THE THREE SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12045895 ↗InjuryJun 22, 2021Migration; Migration
IT WAS REPORTED VIA XRAY THAT 3 DENALI SET SCREWS LOOSENED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTS WERE EXPLANTED. THIS REPORT CAPTURES THE SECOND OF THE THREE SET SCREW/BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12045894 ↗InjuryJun 22, 2021Migration; Migration
IT WAS REPORTED VIA XRAY THAT 3 DENALI SET SCREWS LOOSENED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTS WERE EXPLANTED. THIS REPORT CAPTURES THE THIRD OF THE THREE SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12045873 ↗InjuryJun 7, 2021Migration; Migration
IT WAS REPORTED THAT 4 DENALI BLOCKERS LOOSENED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTS WERE EXPLANTED. THIS REPORT CAPTURES THE FOURTH OF THE FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952526 ↗InjuryJun 7, 2021Migration; Migration
IT WAS REPORTED THAT 4 DENALI BLOCKERS LOOSENED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTS WERE EXPLANTED. THIS REPORT CAPTURES THE THIRD OF THE FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952513 ↗InjuryJun 7, 2021Migration; Migration
IT WAS REPORTED THAT 4 DENALI BLOCKERS LOOSENED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTS WERE EXPLANTED. THIS REPORT CAPTURES THE SECOND OF THE FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952483 ↗InjuryJun 7, 2021Migration; Migration
IT WAS REPORTED THAT 4 DENALI BLOCKERS LOOSENED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTS WERE EXPLANTED. THIS REPORT CAPTURES THE FIRST OF THE FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952455 ↗MalfunctionJun 5, 2020Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING "MILD PAIN IN THE OPERATED AREA" APPROXIMATELY FIVE MONTHS AFTER IMPLANT SURGERY. X-RAY IMAGING INDICATED MIGRATION OF A DENALI SET SCREW HAS OCCURRED. THERE ARE NO PLANS FOR REVISION SURGERY AT THIS TIME.
Patient problems: Pain
MAUDE report 10124109 ↗InjuryMay 19, 2020Migration; Migration
IT WAS REPORTED THAT A DENALI ATR SET SCREW MIGRATED POST-OPERATIVELY. THE PATIENT REPORTED TO HAVE LOCALIZED PAIN. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE MIGRATED SET SCREW.
Patient problems: Injury; Pain
MAUDE report 10072446 ↗InjurySep 25, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOUR DENALI SET SCREWS BACKED-OUT POST-OPERATIVELY LEADING TO REVISION SURGERY. THIS RECORD CAPTURES THE THIRD OF THE FOUR SET SCREWS.
Patient problems: Injury; No Code Available
MAUDE report 9120803 ↗InjurySep 25, 2019Device Dislodged or Dislocated; Migration; Migration
A PHYSICIAN REPORTED FOUR DENALI SET SCREWS BACKED-OUT POST-OPERATIVELY LEADING TO REVISION SURGERY. THIS RECORD CAPTURES THE SECOND OF THE FOUR SET SCREWS.
Patient problems: Injury; No Code Available
MAUDE report 9120801 ↗InjurySep 25, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOUR DENALI SET SCREWS BACKED-OUT POST-OPERATIVELY LEADING TO REVISION SURGERY. THIS RECORD CAPTURES THE FOURTH OF THE FOUR SET SCREWS.
Patient problems: Injury; No Code Available
MAUDE report 9120800 ↗InjurySep 25, 2019Device Dislodged or Dislocated; Migration; Migration
A PHYSICIAN REPORTED FOUR DENALI SET SCREWS BACKED-OUT POST-OPERATIVELY LEADING TO REVISION SURGERY. THIS RECORD CAPTURES THE FIRST OF THE FOUR SET SCREWS.
Patient problems: Injury; No Code Available
MAUDE report 9120798 ↗InjuryJul 20, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED K2M INC ON (B)(6) 2016 THAT TWO SET SCREWS BACKED OUT ALMOST FOUR YEARS POST-OP. THE PATIENT WAS REVISED (B)(6) 2016.
Patient problems: No Information
MAUDE report 5808068 ↗InjuryJul 8, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON (B)(6 2016 THAT A SET SCREW BACKED OUT APPROXIMATELY TWO MONTHS POST-OP. PATIENT WAS REVISED (B)(6) 2016.
Patient problems: No Information
MAUDE report 5778874 ↗MalfunctionJun 28, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A SET SCREW BACK OUT OCCURRED APPROXIMATELY 16 MONTHS POST-OP.
Patient problems: No Information
MAUDE report 5756185 ↗InjuryJun 24, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON 05/26/2016 THAT A POST-OP SET SCREW BACK OUT OCCURRED AT THE DISTAL END OF THE CONSTRUCT. THE PATIENT WAS REVISED ON (B)(6) 2015.
Patient problems: No Information
MAUDE report 5749176 ↗InjuryJun 21, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC ON 5/29/2016 THAT THERE WAS A SECOND REVISION SURGERY APPROXIMATELY ONE MONTH POST-OP AFTER THE INITIAL REVISION SURGERY FOR SET SCREW BACK-OUTS. EXACT REVISION DATE UNKNOWN.
Patient problems: No Information
MAUDE report 5739856 ↗InjuryMay 25, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT TWO SET SCREWS BACKED OUT AT THE DISTAL END OF THE CONSTRUCT POST-OPERATIVELY.
Patient problems: No Information
MAUDE report 5679127 ↗MalfunctionMay 25, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A SET SCREW BACKED OUT AT THE DISTAL END OF THE CONSTRUCT POST-OPERATIVELY.
Patient problems: No Information
MAUDE report 5679082 ↗InjuryMay 25, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A POST-OP SET SCREW BACK OUT OCCURRED AT THE DISTAL END OF THE CONSTRUCT.
Patient problems: No Information
MAUDE report 5679068 ↗InjuryMay 17, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON 04/20/2016 THAT A REVISION SURGERY WOULD TAKE PLACE ON (B)(6) 2016 FOR SET SCREW BACK OUTS.
Patient problems: No Information
MAUDE report 5660876 ↗InjuryMar 18, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT THERE WAS A REVISION SURGERY APPROXIMATELY 3 MONTHS POST-OP FOR A SET SCREW BACK OUT.
Patient problems: No Information
MAUDE report 5510180 ↗InjurySep 29, 2015Device Slipped
IT WAS REPORTED TO K2M, INC ON 01/13/2010 THAT SET SCREWS LOOSENED FROM THE PEDICLE SCREWS POST-OP AT L4-S1. REVISION SURGERY TOOK PLACE ON (B)(6) 2010.
Patient problems: No Information
MAUDE report 5112336 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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.
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