N/A 5407FA2023SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327096712), received between May 8, 2018 and May 20, 2025 — classified as 7 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. 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.

• MalfunctionMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT A ROUTER BROKE DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. INFORMATION REGARDING MEDICAL INTERVENTION AND SURGICAL DELAY HAVE BEEN REQUESTED FROM THE CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053582 ↗
• MalfunctionApr 21, 2025Fracture; 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 21876629 ↗
• MalfunctionApr 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE ROUTER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14117609 ↗
• MalfunctionApr 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE IT WAS NOTED THE ROUTER WAS BROKEN AT THE BASE IN THE ASSOCIATED ATTACHMENT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691685 ↗
• MalfunctionJul 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING, PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BUR WAS BROKEN IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10257319 ↗
• MalfunctionApr 8, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE ROUTER BROKE AND FLEW IN THE AIR HITTING A PERSON IN THE UPPER BODY. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 8491389 ↗
• MalfunctionMay 8, 2018Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL BILATERAL LAMINECTOMY, THE ROUTER BROKE INTO THREE PIECES. 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

  MAUDE report 7495286 ↗