DENALI Spinal System 101-90208Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857010529), received between Jan 4, 2021 and Jun 30, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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.

• MalfunctionJun 30, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE DENALI TORQUE LIMITING SHAFT BROKE OFF DURING THE FINAL TIGHTENING OF THE SET SCREWS. AN AVAILABLE SPARE SET WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE SECOND OF TWO TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094561 ↗
• MalfunctionMay 11, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF 4 DENALI TORQUE LIMITING SHAFT FRACTURED INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE FOURTH OF THE FOUR TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806398 ↗
• MalfunctionMay 11, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF 4 DENALI TORQUE LIMITING SHAFT FRACTURED INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE FIRST OF THE FOUR TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806396 ↗
• MalfunctionMay 11, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF 4 DENALI TORQUE LIMITING SHAFT FRACTURED INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE SECOND OF THE FOUR TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806361 ↗
• MalfunctionMay 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SCOLIOSIS SURGERY, IT WAS NOTICED THAT THE TIP DEFORMED OF A DENALI TORQUE LIMITING SHAFT DURING SCREW REMOVAL. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761581 ↗
• MalfunctionJan 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING FINAL TIGHTENING, TWO DENALI SPINAL SYSTEM TORQUE LIMITING SHAFTS TWISTED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MIN SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT REPRESENTS THE SECOND OF THE TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108067 ↗