NA 03.630.909Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034718606), received between Mar 10, 2020 and Mar 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 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 10, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FACET FUSION, DURING THE INSERTION OF A MTF BONE DOWEL, THE SCREWDRIVER/INSERTER BROKE. ALL PIECES WERE REMOVED EASILY FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN MTF BIOLOGICS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.0MM HEX DRIVER SHAFT FEMALE QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812001 ↗