COALITION MIS 1136.2012Recalls & reported problems
Globus Medical, Inc. · COALITION MIS Anchor, 12mm · Class 2 · Implant
Data updated Oct 16, 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 00889095358940), received between Jan 25, 2021 and Mar 5, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Malposition of Device1
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A COALITION MIS ANCHOR BACKING OUT POST-OPERATIVELY. THE IMPLANT'S SET SCREW ALSO MIGRATED ANTERIORLY. THIS EVENT OCCURRED IN HONG KONG.
Patient problems: Insufficient Information
MAUDE report 18837567 ↗InjuryJan 25, 2021Difficult to Remove; Malposition of Device
IT WAS REPORTED THAT 2 COALITION MIS ANCHORS WERE ADVANCED TOO FAR CAUSING THE PATIENT TO LOSE MOTORS. THE ANCHORS WERE UNABLE TO BE RETRIEVED WITH THE REMOVAL TOOL, RESULTING IN THE SURGEON PERFORMING A CORPECTOMY TO REMOVE THE CAGE AND SCREWS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11226786 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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