Skip to content

REVOLVE 185.464Recalls & reported problems

Globus Medical, Inc. · 6.5mm REVOLVE Polyaxial Pedicle Screw, 40mm · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849044070941), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 13, 2022Material Separation

    IT WAS REPORTED THERE WAS A REVISION FOR A REVOLVE SCREW HEAD THAT SEPARATED FROM THE SHANK POST OPERATIVELY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14103989 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.