Skip to content

COLONIAL 365.106Recalls & reported problems

Globus Medical, Inc. · Colonial ACDF Spacer, Small, Lordotic, 6mm · 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 00849044029222), received between Jan 4, 2021 and Jan 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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

  • 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.

  • MalfunctionJan 4, 2021Migration

    IT WAS REPORTED BY A REPRESENTATIVE FROM (B)(4) THAT A REVISION WAS DONE FOR A COLONIAL ACDF SPACER WHICH HAD BACKED OUT POST-OPERATIVELY.

    Patient problems: Insufficient Information

    MAUDE report 11113537 ↗

Other Intervertebral fusion device with bone graft, cervical devices

All Intervertebral fusion device with bone graft, cervical devices →

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