Medtronic Reusable Instruments 8114505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994594471), received between Aug 10, 2020 and Aug 10, 2020 — 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.

• MalfunctionAug 10, 2020Break; Break

  INFORMATION RECEIVED FROM THE INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PRE-OPERATIVE DIAGNOSIS OF SCOLIOSIS. IT WAS REPORTED THAT THE BENDER WAS BROKEN WHEN THE CROSSLINK WAS BEING BENT. THERE WERE NO FRAGMENTS LEFT IN PATIENT AND WAS NO DELAY IN SURGERY DUE TO THIS EVENT. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED DUE TO THIS EVENT. THERE WERE NO PATIENT SYMPTOMS REPORTED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON 05-AUG-2020: IT WAS REPORTED THAT THE CROSS LINK WAS BROKEN, AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10383626 ↗