MaXcess 1011419Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517065834), received between Nov 15, 2022 and Oct 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE, THE UPPER JAW OF THE PITUITARY RONGEUR FRACTURED OFF. THE FRACTURED PORTION WAS RETRIEVED FROM THE SURGICAL SITE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022331 ↗
• MalfunctionJul 7, 2023Mechanical Problem; Mechanical Problem

  IT WAS INITIALLY REPORTED THAT THE PITUITARY'S "CLOSURE WAS NO LONGER EFFECTIVE". NO ADVERSE PATIENT, USER, OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE. UPON EVALUATION BY NUVASIVE SERVICING PERSONNEL, IT WAS FOUND THE UPPER JAW TIP WAS FRACTURED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280003 ↗
• MalfunctionNov 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINAL PROCEDURE THE DISTAL ARTICULATING TIP OF A PITUITARY FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801580 ↗