REVERE 124.465Recalls & reported problems
Globus Medical, Inc. · 6.5mm REVERE Pedicle Screw 45mm · 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 00849044001242), received between Mar 4, 2024 and Jul 31, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Use of Device Problem1
Patient problems
- Spinal Column Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A L3-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2024. SHE CAME FOR A FOLLOW-UP ON (B)(6) 2025 REPORTING BACKPAIN. CT LUMBAR SPINE DEMONSTRATED FRACTURE OF THE NECK OF THE RIGHT L5 PEDICLE SCREW. CT LUMBAR SPINE WAS PERFORMED ON (B)(6) 2025. THIS EVENT OCCURRED IN NAMIBIA.
Patient problems: Spinal Column Injury
MAUDE report 22676947 ↗MalfunctionMar 4, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT REVISION SURGERY WAS REQUIRED TO REMOVE TWO REVERE PEDICLE SCREWS DUE TO NON-UNION AND LOOSENING AT L4.
Patient problems: Spinal Column Injury
MAUDE report 18831124 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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