COALITION MIS 1136.2011Recalls & reported problems
Globus Medical, Inc. · COALITION MIS Anchor, 11mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095389999), received between Nov 7, 2021 and Oct 28, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).
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
- Migration or Expulsion of Device2
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- Insufficient Information3
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Migration; Migration
IT WAS REPORTED THAT BOTH ANCHORS BACKED OUT AFTER THE SURGERY. THE ANCHORS WERE REMOVED AND AN XTEND PLAT WAS PLACED OVER THE COALITION MIS TI SPACER. THE ANCHORS WERE REMOVED AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407576 ↗MalfunctionMar 5, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A COALITION MIS ANCHOR HAS MIGRATED POST OPERATIVELY. THIS EVENT OCCURRED IN SWITZERLAND.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18837805 ↗MalfunctionMar 5, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A COALITION MIS ANCHOR HAS MIGRATED POST OPERATIVELY. THIS EVENT OCCURRED IN SWITZERLAND.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18837792 ↗MalfunctionNov 7, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPLACE A COALITION MIS ANCHOR DISLODGED WITH SPACER SUBSIDENCE 3 MONTHS POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 12760258 ↗
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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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