Medtronic Reusable Instruments 2980008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074318035), received between Mar 23, 2022 and Mar 23, 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 18, 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.

• MalfunctionMar 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPACER USING AN INSERTER IN A L4-5 PLIF FOR AN L4-5 STENOSIS. IT WAS REPORTED THAT THE SURGEON IMPLANTED THE SPACER IN THE L4-5 SPACE ON THE LEFT SIDE. A PIECE OF THE INSERTER BROKE. THE HCP RECOVERED THE BROKEN PIECE AND A BACKUP INSERTER WAS USED FOR THE OTHER IMPLANT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13857281 ↗