COLONIAL 365.407Recalls & reported problems
Globus Medical, Inc. · Colonial ACDF Spacer, Large, Lordotic, 7mm · 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 00849044029390), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Fracture; Fracture
THE PATIENT PRESENTED WITH PAIN POST-OPERATIVELY. IT WAS FOUND THEY HAD A NON-UNION AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE SPACER AND PLATE.
Patient problems: Failure of Implant
MAUDE report 18826092 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.