NA 324.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034769332), received between Apr 17, 2019 and Apr 17, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE FOUR INSERTION SCREWDRIVERS SELF-RETAINING ARE OLD AND BECOMING VERY DULL AND NO LONGER SELF-RETAINING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION SCREWDRIVER. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522622 ↗
• MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE FOUR INSERTION SCREWDRIVERS SELF-RETAINING ARE OLD AND BECOMING VERY DULL AND NO LONGER SELF-RETAINING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN.   THIS REPORT IS FOR ONE (1) INSERTION SCREWDRIVER. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522621 ↗
• MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE FOUR INSERTION SCREWDRIVERS SELF-RETAINING ARE OLD AND BECOMING VERY DULL AND NO LONGER SELF-RETAINING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION SCREWDRIVER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522620 ↗
• MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE FOUR INSERTION SCREWDRIVERS SELF-RETAINING ARE OLD AND BECOMING VERY DULL AND NO LONGER SELF-RETAINING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION SCREWDRIVER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522614 ↗