NA 698331539Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034328867), received between Nov 29, 2017 and Nov 29, 2017 — classified as 1 injury.

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.

• InjuryNov 29, 2017Break; Break

  IT WAS REPORTED SURGEON WAS TAPPING THE LEFT L5 PEDICLE WHEN THE TAP BROKE OFF IN THE PEDICLE. BOTH PIECES OF THE TAP WERE ABLE TO BE RETRIEVED. LATER IN THE CASE, SURGEON SHEARED THE TIP OFF OF A DRIVER WHILE INSERTING THE RIGHT L5 SCREW. SURGEON TRIED TO REMOVE SCREW BY HELICOPTERING IT OUT. WHILE DOING THIS, THE HEAD SHEARED FROM THE SCREW SHANK. BOTH WERE REMOVED. SURGEON INSERTED A LARGER DIAMETER SCREW AT THE SAME LEVEL AND ANOTHER DRIVER TIP SHEARED. TWO AND HALF HOUR DELAY AND BLOOD LOSS WAS REPORTED.

  Patient problems: Blood Loss; Not Applicable

  MAUDE report 7068359 ↗