N/A 2940357Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074087856), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF DUE TO UNK NOWN INDICATION. IT WAS REPORTED THAT THE 8MM SILVER SHAVER FROM THE POSTERIOR MICROSCOPE INSTRUMENT SET BROKE OFF INTO THE PATIENTS DISC SPACE AND AFTER HOURS OF TRYING TO GET IT OUT THE SURGEON WAS ABLE TO PULL IT OUT WITH A 4MM PITUITARY AND IMPLANTING ELEVATE ON THE CONTRALATERAL SIDE TO INCREASE THE DISC SPACE PROVIDING MORE ROOM TO ACCESS THE BROKEN PIECE. SURGEON HAD TO OPEN THE CONTRALATERAL DISC SPACE AND PUT AN IMPLANT IN, THUS INCREASING THE HEIGHT OF THE DISC SPACE ALLOWING HIM TO GO BACK IN THE OPPOSITE SIDE AND PULL THE BROKEN SHAVER OUT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105313 ↗