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NA 698326166Recalls & reported problems

Depuy Spine, LLC · MODIFIED INSTRUMENT DRIVER T20 · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034313009), received between Nov 28, 2018 and Nov 28, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 28, 2018Break; Break

    IT WAS REPORTED THAT DR. (B)(6) HAS CUSTOM EXPEDIUM DRIVERS. HE WAS PERFORMING A LUMBAR FUSION THAT WAS A REVISION. HE REMOVED THE PREVIOUS SCREWS AND WAS ¿UPSIZING¿ THEM. AS HE WAS PUTTING IN A 7.5X50 SCREW, THE TIP OF THE SCREW DRIVER BROKE OFF IN THE SCREW. WE REMOVED THAT SCREW USING A DEVICE DESIGNED TO BACK OUT SCREWS. HE TRIED AGAIN WITH THE SAME SIZE SCREW AND BROKE ANOTHER DRIVER OFF INTO THE SCREW. WE REMOVED THAT ONE USING THE SAME TECHNIQUE. HE THEN TRIED A DIFFERENT SIZE SCREW AND IT WORKED FINE. THE CASE FINISHED AS PLANNED AND THE SURGEON WAS PLEASED WITH THE OUTCOME. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8112559 ↗
  • MalfunctionNov 28, 2018Break; Break

    IT WAS REPORTED THAT DR. (B)(6) HAS CUSTOM EXPEDIUM DRIVERS. HE WAS PERFORMING A LUMBAR FUSION THAT WAS A REVISION. HE REMOVED THE PREVIOUS SCREWS AND WAS ¿UPSIZING¿ THEM. AS HE WAS PUTTING IN A 7.5X50 SCREW, THE TIP OF THE SCREW DRIVER BROKE OFF IN THE SCREW. WE REMOVED THAT SCREW USING A DEVICE DESIGNED TO BACK OUT SCREWS. HE TRIED AGAIN WITH THE SAME SIZE SCREW AND BROKE ANOTHER DRIVER OFF INTO THE SCREW. WE REMOVED THAT ONE USING THE SAME TECHNIQUE. HE THEN TRIED A DIFFERENT SIZE SCREW AND IT WORKED FINE. THE CASE FINISHED AS PLANNED AND THE SURGEON WAS PLEASED WITH THE OUTCOME. PATIENT CONSEQUENCE? : NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8112525 ↗

Other DRIVER, PROSTHESIS devices

All DRIVER, PROSTHESIS devices →

Sources and updates

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