DENALI Spinal System 101-90054Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857009868), received between Nov 20, 2019 and Apr 29, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE TIP OF A DENALI THORACIC PROBE "BROKE" INTRA-OPERATIVELY. ALL PIECES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11746170 ↗
• MalfunctionJan 28, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE A DENALI THORACIC PROBE FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247523 ↗
• MalfunctionDec 14, 2020Fracture; Fracture

  THE PHYSICIAN REPORTED THAT DURING LUMBAR SPINE CORRECTION, THE DENALI SPINAL SYSTEM THORACIC PROBE TIP FRACTURED WHILE DRILLING THE PILOT HOLE AT LEFT L5 INTRA-OPERATIVELY. THE TIP WAS RETRIEVED IMMEDIATELY FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER THORACIC PROBE WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11005679 ↗
• MalfunctionMar 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT A DENALI SPINAL SYSTEM THORACIC PROBE FRACTURED INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9777281 ↗
• MalfunctionNov 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT A DENALI THORACIC PROBE TIP FRACTURED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9349853 ↗