na 9569566Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074451213), received between Sep 7, 2020 and May 5, 2022 — classified as 3 malfunctions.

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

• MalfunctionMay 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR DISCECTOMY THERAPY. LEVELS IMPLANTED 1. IT WAS REPORTED THAT DURING DISCECTOMY THE INSTRUMENT WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THE INSTRUMENT BROKEN DURING THE PROCEDURE BUT HOSPITAL DENIED PROVIDING PATIENT DETAILS. EVENT HAPPENED DURING PROCEDURE BUT NO HARM HAPPENED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285115 ↗
• MalfunctionDec 18, 2020Break; Break

  INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT DIAGNOSED WITH SPINAL STENOSIS, DEGENERATIVE DISC DISEASE AND SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE TIP PART OF PITUITARY WAS BROKEN. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT WAS PERFORMED AS A RESULT OF THIS EVENT. IT WAS MENTIONED THAT THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED. THERE WERE NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON 2020-DEC-09: IT WAS REPORTED THAT THERE WAS NO DELAY REPORTED AS A RESULT OF THIS EVENT. IT WAS MENTIONED THAT THE PRODUCT CAME IN CONTACT WITH PATIENT BUT, NO ADVERSE EVENT OCCURRED. THERE WERE NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11035842 ↗
• MalfunctionSep 7, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF HERNIATED DISC L3 AND L4. IT WAS REPORTED THAT THE PITUITARY BREAK. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THIS EVENT. PROCEDURE USED IS MICRODISSECTOMY. DURING A HERNIATED DISC PROCEDURE, THE TIP OF THE FORCEPS BROKE. FRAGMENT REMAINED INSIDE THE DISC. IT WAS NOT POSSIBLE TO REMOVE THE FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10498895 ↗