DENALI® Spinal System 111-B55500Recalls & reported problems
VB Spine LLC · 111-B55500 · Class 2 · Implant
All models of DENALI Spinal System (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857018495), received between Oct 16, 2015 and Dec 6, 2021 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Break2
- Device Operates Differently Than Expected1
Patient problems
- No Information3
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2021Fracture; Fracture
IT WAS REPORTED THAT A MESA DEFORMITY STRAIGHT RAIL AND A DENALI DEFORMITY STRAIGHT ROD BROKE 18 MONTHS POST -OPERATIVELY. REVISION WILL BE PERFORMED, BUT HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE DENALI DEFORMITY STRAIGHT ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12941540 ↗MalfunctionNov 22, 2019Fracture; Fracture
A PHYSICIAN REPORTED THAT A DENALI STRAIGHT DEFORMITY ROD BROKE APPROXIMATELY 7 TO 9 MONTHS FOLLOWING IMPLANTATION. THE PATIENT IS EXPERIENCING BACK PAIN BUT REVISION SURGERY IS NOT CURRENTLY PLANNED.
Patient problems: Pain
MAUDE report 9364507 ↗InjuryApr 5, 2017Break; Break
ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH BROKEN RODS WERE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2016.
Patient problems: No Information
MAUDE report 6460523 ↗InjuryMar 29, 2017Break; Break
ON 02.27.2017 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH BROKEN RODS WERE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2017.
Patient problems: No Information
MAUDE report 6442304 ↗InjuryFeb 10, 2016Fracture; Fracture
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A REVISION SURGERY TOOK PLACE DUE TO A FRACTURED ROD.
Patient problems: No Information
MAUDE report 5427147 ↗InjuryOct 16, 2015Device Operates Differently Than Expected
IT WAS REPORTED TO K2M, INC ON (B)(6) 2015 THAT THE SURGEON WAS UNABLE TO IMPLANT THE RODS DURING THE INITIAL CASE DUE TO THE EXTENDED PERIOD OF TIME IT TOOK TO INSERT THE SCREWS. THE LENGTH OF THE SCREW INSERTERS ATTACHED TO THE HANDLES CAUSED THE INSTRUMENTATION TO INTERFERE WITH THE C-ARM. THE SURGEON HAD TO PLACE ALL OF THE SCREWS BY HAND WITHOUT A HANDLE ATTACHED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5155430 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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