CONCORDE® ProTi 360°™ 188823111Recalls & reported problems
Tyber Medical, LLC · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917020786), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intervertebral Disc Compression or Protrusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVENT WAS IDENTIFIED AS PART OF A RETROSPECTIVE CLINICAL STUDY: AT 15 MONTHS POST OPERATIVE, THE SUBJECT WAS RADIOGRAPHICALLY FUSED WITH GRADE 3 GRAFT INCORPORATION BUT HAD CAUDAL SUBSIDENCE.
Patient problems: Intervertebral Disc Compression or Protrusion
MAUDE report 21414764 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.