Skip to content

CONCORDE® ProTi 360°™ 188823409Recalls & reported problems

Tyber Medical, LLC · 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 00819917020939), received between Jan 6, 2020 and Jan 6, 2020 — 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
  • Migration or Expulsion of Device1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

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

  • MalfunctionJan 6, 2020Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

    PRIMARY IMPLANTED ON (B)(6) 2019. WITHIN A COUPLE MONTHS OF THE SURGERY, IT WAS DISCOVERED THAT ONE OF THE TWO CAGES STARTED TO BACK OUT. SURGEON FELT IT BEST TO SIMPLY REMOVE. LACK OF FUSION. NO BELIEF OF PRODUCT FAILURE. ACTION TAKEN : CAGE REMOVED.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 9555743 ↗

Other Intervertebral fusion device with bone graft, lumbar devices

All Intervertebral fusion device with bone graft, lumbar devices →

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