DENALI Spinal System 101-90317Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857011267), received between Aug 11, 2020 and Dec 12, 2020 — classified as 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT WHEN TRYING TO FINAL TIGHTEN A SCREW, THE DENALI SPINAL SYSTEM TORQUE INDICATING WRENCH TIP FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER TOOL FOR FINAL TORQUEING WITH A 5 MIN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995584 ↗
• MalfunctionAug 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DENALI TORQUE INDICATING WRENCH BROKE OFF INTRA-OPERATIVELY. THE TIP WAS REMOVED AND SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10392378 ↗