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CREO 5119.1732Recalls & reported problems

Globus Medical, Inc. · CREO® Threaded 7.5 x 30mm Polyaxial Screw · 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 00889095104639), received between Nov 11, 2020 and Apr 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1
  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 9, 2021Migration

    IT WAS REPORTED BY A REPRESENTATIVE FROM (B)(6), THAT A REVISION SURGERY WAS DONE DUE TO A SCREW AT S1 DEVIATING POST-OPERATIVELY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11644975 ↗
  • MalfunctionNov 11, 2020Loose or Intermittent Connection

    IT WAS REPORTED THAT A SCREW AT S1 LOOSENED POST-OPERATIVELY. A REVISION WAS DONE TO REMOVE AND REPLACE THE SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10823611 ↗

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.