REVOLVE 185.465Recalls & reported problems
Globus Medical, Inc. · 6.5mm REVOLVE Polyaxial Pedicle Screw, 45mm · Class 2
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 00849044070958), received between Mar 1, 2024 and Jun 28, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Separation1
Patient problems
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Fracture; Fracture
IT WAS REPORTED THAT A REVISION WAS NEEDED DUE TO A REVOLVE SCREW THAT WAS FOUND BROKEN POST OPERATIVELY. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Insufficient Information
MAUDE report 19637081 ↗MalfunctionMar 5, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE SCREW HEAD BROKE OFF THE SCREW SHANK POST-OPERATIVELY REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 18837712 ↗MalfunctionMar 1, 2024Fracture; Fracture
IT WAS REPORTED THAT TWO REVOLVE SCREWS BROKE AT THE SHAFT.
Patient problems: Insufficient Information
MAUDE report 18816286 ↗
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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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