DENALI Spinal System 101-90295Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857011076), received between Sep 11, 2020 and Jun 29, 2022 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT A DENALI SPINAL SYSTEM CURVED THORACIC PEDICLE PROBE BROKE INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14856290 ↗
• MalfunctionFeb 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DENALI CURVED THORACIC PROBE BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER PROBE AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375480 ↗
• MalfunctionSep 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DENALI CURVED THORACIC PROBE FRACTURED OFF DURING INTRA-OPERATIVE SCREW HOLE PREPARATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY USING AN ALTERNATIVE INSTRUMENT. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

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

  MAUDE report 10525389 ↗