NA 5450815107Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613252518389), received between Jul 17, 2018 and Jul 29, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Fracture; Fracture

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647058 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818173 ↗
• MalfunctionApr 15, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113249 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985878 ↗
• MalfunctionNov 23, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A JAWBONE OSTEOTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED A SUPERFICIAL BURN TO THE UPPER LIP ANTERIOR NASAL WING IT WAS FURTHER REPORTED THAT THE BURN WAS TREATED WITH OINTMENT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15854862 ↗
• MalfunctionJun 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE, WHILE CUTTING LAMINA, THE KNIFE TIP BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212386 ↗
• MalfunctionMay 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE KNIFE BROKE OFF DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10079899 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF THE KNIFE BROKE OFF DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THE BROKEN TIP HAD TO BE RETRIEVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT IT WAS A SPINAL CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680331 ↗
• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE KNIFE TIP BROKE OFF IN THE PATIENT'S BONE. THE USER FACILITY REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY, AND THAT THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7694622 ↗