REVOLVE 185.000Recalls & reported problems
Globus Medical, Inc. · REVOLVE Locking Cap · Class 2
- 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 00849044070569), received between Mar 4, 2024 and Mar 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Product Quality Problem1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED THAT DURING A REVISION SURGERY A REVOLVE LOCKING CAP WAS FOUND TO BE BROKEN WHEN IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 18837603 ↗MalfunctionMar 4, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT DURING SURGERY A REVOLVE LOCKING CAP WENT THROUGH THE PSOAS AND WAS LOST NEAR THE PERITONEUM AND LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Insufficient Information
MAUDE report 18827147 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.