DENALI® Spinal System 101-A55500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857011540), received between Aug 7, 2019 and Jan 13, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (4 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

Recent adverse event reports

The 6 most recent of 6 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 FIRST OF TWO MESA PEDICLE SCREWS.

  Patient problems: Tissue Breakdown

  MAUDE report 15601311 ↗
• InjuryAug 8, 2019Break; Fracture; Improper or Incorrect Procedure or Method; Fracture

  A PHYSICIAN REPORTED THAT A DENALI STRAIGHT DEFORMITY ROD BROKE AT THE T12 TO L1 LEVEL. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS PERFORMING CONTRAINDICATED EXERCISES (BENDING TO TOUCH THEIR TOES) AS SHE WAS DOING EVERY MORNING PRIOR TO HER INITIAL SURGERY. THIS RECORD REPRESENTS 1 OF 2 RODS.

  Patient problems: Injury

  MAUDE report 8875408 ↗
• InjuryAug 7, 2019Break; Fracture; Improper or Incorrect Procedure or Method; Material Deformation; Fracture

  A PHYSICIAN REPORTED THAT A DENALI STRAIGHT DEFORMITY ROD BROKE AT THE T12 TO L1 LEVEL. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS PERFORMING CONTRAINDICATED EXERCISES (BENDING TO TOUCH THEIR TOES) AS SHE WAS DOING EVERY MORNING PRIOR TO HER INITIAL SURGERY. THIS RECORD REPRESENTS 2 OF 2 RODS.

  Patient problems: Injury

  MAUDE report 8869442 ↗