N/A 5484305Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREWDRIVER 5484305 MAS T25 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994761590), received between Nov 25, 2023 and Sep 9, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVERS WERE BROKEN. NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004758 ↗MalfunctionAug 19, 2025Break; Break
16 SEP 2025, UPDATE RECEIVED: THE TIP OF THE SCREWDRIVER BROKE WHILE TRYING TO REMOVE A SCREW. THE SCREWDRIVER WAS BEING USED PROPERLY. HARDWARE REMOVAL WAS DUE TO PATIENT CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22838964 ↗MalfunctionMay 14, 2024Break; Break
INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT SCREWDRIVER TIP BROKE. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. EVENT HAPPENED DURING INTRA OP PLACING A PEDICLE SCREW.WHILE PULLING OFF SCREWDRIVER AFTER PLACING PEDICLE SCREW, THE T25 TIP OF THE SCREWDRIVER BECAME UNATTACHED (BROKE) OFF THE INNER SHAFT OF THE DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19310249 ↗MalfunctionNov 25, 2023Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED FOR SCOLIOSIS. IT WAS REPORTED THAT THE DRIVERS WERE STRIPPED. THERE WERE NO PATIENT SYMPTOMS IN THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18207580 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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