DENALI Spinal System 101-90101Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888857010048), received between Aug 11, 2020 and Jun 30, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 FIRST OF TWO TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094512 ↗
• MalfunctionJun 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT A DENALI TORQUE LIMITING SHAFT BROKE OFF DURING SET SCREW REMOVAL INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995769 ↗
• 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 THIRD OF THE FOUR TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806238 ↗
• MalfunctionJan 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SCHEDULED REVISION, THE TIP OF A DENALI TORQUE LIMITING SHAFT BROKE DURING SCREW INSERTION. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193166 ↗
• 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 FIRST TORQUE LIMITING SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108068 ↗
• MalfunctionNov 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A DENALI TORQUE LIMITING SHAFT TIP DEFORMED INTRA-OPERATIVELY. THE INSTRUMENT TIP TWISTED WHILE ATTEMPTING TO REMOVE AN S1 SCREW, THAT WAS DIFFICULT TO REMOVE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH A 10 MINUTE SURGICAL DELAY, BY USING A T-BAR REMOVAL TOO AND USING A NEW SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10825598 ↗
• MalfunctionAug 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF A DENALI TORQUE LIMITING SHAFT STRIPPED DURING FINAL TORQUING INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH SECOND SHAFT AND 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 10392506 ↗