REVERE 524.100Recalls & reported problems
Globus Medical, Inc. · REVERE 5.5 Threaded Locking Cap · Class 2
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 00889095160246), received between Dec 31, 2020 and May 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Migration; Migration
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REMOVE REVERE LOCKING CAPS THAT WERE FOUND TO BE LOOSE. THIS EVENT OCCURRED IN SWEDEN.
Patient problems: Insufficient Information
MAUDE report 22013633 ↗MalfunctionDec 31, 2020Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED BY A REPRESENTATIVE FROM SPAIN THAT A REVISION WAS DONE DUE TO LOCKING CAPS THAT CAME LOOSE POST-OPERATIVELY WITH SUBSEQUENT ROD MIGRATION OUT OF THE SCREW HEAD CAUSING PATIENT PAIN.
Patient problems: Pain
MAUDE report 11102132 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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