REVERE 124.464Recalls & reported problems
Globus Medical, Inc. · 6.5mm REVERE Pedicle Screw 40mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849044001235), received between Mar 5, 2024 and Feb 24, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Migration
IT WAS REPORTED THAT THE SURGEON REMOVED FOUR LOOSE SCREWS AND REPLACED WITH FOUR HA COATED SCREWS. THESE WERE REPLACED WITH 4 HA SCREWS IN SAME LENGTH BUT IN 7.5 DIAMETER. THE LOCK CAPS AND 2 50MM RODS WERE ALSO REMOVED AND REPLACED WITH NEW. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE CASE WAS FINISHED AND ALL WENT WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434348 ↗MalfunctionMar 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE A 6.5MM REVERE PEDICLE SCREW DUE TO SURGEON MISPLACEMENT.
Patient problems: Insufficient Information
MAUDE report 18837543 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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