CONCORDE® ProTi 360°™ 188827409Recalls & 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 00819917021295), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
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.
InjuryNov 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THIS WAS A TRANSFORAMINAL LUMBAR INTERBODY FUSION (L5/S1) FOR LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2023. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023 WITH CONCORDE. AFTER THE SURGERY, THE BACKED OUT OF CONCORDE IN QUESTION WAS CONFIRMED ON AN UNKNOWN DATE. ON (B)(6) 2023, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SET SCREW (EXPEDIUM VERSE) AND THE ROD AND TO HUMMER THE CONCORDE IN 5 MM. THE SURGEON APPLIED COMPRESSION BETWEEN THE SCREWS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18163452 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.