N/A 693.600Recalls & reported problems
Globus Medical, Inc. · Lateral Torque-Limiting Driver, 3.0Nm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095058451), received between Mar 2, 2024 and Sep 1, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture3
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547748 ↗MalfunctionMar 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE LATERAL TORQUE LIMITING DRIVER SHEERED OFF WHILE INSTALLING A SCREW AND WAS LEFT IN THE PATIENT POST-OP. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 21633810 ↗MalfunctionMar 2, 2024Fracture; Fracture
IT WAS REPORTED THE TIP OF THE LATERAL TORQUE LIMITING DRIVER BROKE OFF IN THE EXPANSION SCREW OF AN ELSA SPACER. THE INSTRUMENT TIP WAS UNABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 18823389 ↗
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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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