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COALITION 184.052Recalls & reported problems

Globus Medical, Inc. · 4.2mm Bone Screw, Variable, Self-Drilling, 12mm · Class 2 · Implant

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 00849044007510), received between Sep 19, 2022 and Sep 19, 2022 — classified as 1 malfunction.

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

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionSep 19, 2022Migration; Loose or Intermittent Connection; Migration

    IT WAS REPORTED THAT THERE WAS A REVISION SURGERY TO REPLACE A COALITION BONE SCREW THAT WAS LOOSE AND CAUSED AN ANCHOR TO BACK OUT 3 DAYS POST OPERATIVELY.

    Patient problems: Insufficient Information

    MAUDE report 15445453 ↗

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