NA 03.816.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034730783), received between Sep 1, 2020 and Sep 1, 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.

• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTER ORDERED INSTRUMENTS TO USE IN TRAINING. WHEN THE REPORTER WAS PREPARING TO DO A VIDEO ON THE ASSEMBLY ON THE INSIGHT LATERAL ACCESS SYSTEM, ONE OF THE NEW INSTRUMENTS WAS BROKEN. THE INSTRUMENT FOR BONE ANCHOR/WINGLET/BLADE EXTENSION WAS THREADED INTO THE DESIGNATED SLOT ON THE WINGLET-LEFT AND WAS UNABLE TO UNTHREAD THE DEVICE. THERE WERE MULTIPLE ATTEMPTS TO DISCONNECT THE TWO INSTRUMENTS WHICH RESULTED IN THE TIP OF THE DRIVER BREAKING OFF INSIDE THE WINGLET. THIS RENDERED BOTH ITEMS UNUSABLE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR 1 INSTRUMENT FOR BONE ANCHOR/ WINGLETS AND BLADE EXTENSION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10480537 ↗