DENALI MI Spinal System 1001-90133Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857001121), received between Jul 8, 2016 and Nov 29, 2021 — classified as 1 injury, 4 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE DENALI TORQUE INDICATING WRENCH BROKE OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12884207 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SCHEDULED REVISION, THE TIP OF A DENALI MI TORQUE INDICATING WRENCH FRACTURED WHILE ATTEMPTING TO REMOVE A SET SCREW INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SCREW REMOVAL TOOL, AND NO SURGICAL DELAY. NO ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008385 ↗
• InjuryMay 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT A DENALI MI TORQUE INDICATING WRENCH TIP FRACTURED INTRA-OPERATIVELY. THE FRACTURED TIP WAS STUCK INSIDE IMPLANT AND REMAINED THE PATIENT AS IT WAS NOT ABLE TO BE REMOVED. THERE WAS A SURGICAL DELAY OF OVER AN HOUR.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10103033 ↗
• MalfunctionJun 29, 2017Break; Break

  ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A TORQUE WRENCH TIP SHEARED OFF AND FUSED INTO THE SET SCREW. THE TORQUE WRENCH TIP REMAINS IN THE PATIENT CONFINED TO THE SET SCREW. SURGERY TOOK PLACE (B)(6) 2017.

  Patient problems: No Information

  MAUDE report 6676230 ↗
• MalfunctionJul 8, 2016Break; Break

  IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT THE TIP OF A TORQUE WRENCH BROKE OFF IN A SET SCREW INSIDE THE PATIENT. SURGERY TOOK PLACE (B)(6) 2016.

  Patient problems: No Information

  MAUDE report 5778843 ↗