CONCORDE® ProTi 360°™ 188823410Recalls & reported problems
Tyber Medical, LLC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00819917020946), received between Aug 3, 2021 and Aug 3, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
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.
InjuryAug 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2021 PLIF (L4-5) WAS PERFORMED. THE PATIENT HAS MEDICAL HISTORY OF DM. ON (B)(6) THE PATIENT'S BACK PAIN BECAME WORSE. THE CRP VALUE ROSE, AND IT DID NOT SEEM THAT IT WOULD DECREASE. THEREFORE, THE SURGEON PRESUMED THAT THE PATIENT MIGHT HAVE BECOME INFECTIOUS. THE PATIENT UNDERWENT A REMOVAL PROCEDURE. UPON RECEIPT OF AN EXAMINATION RESULT OF BACTERIA, THEY WILL REMOVE THE CAGES IN QUESTION. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.
Patient problems: Insufficient Information
MAUDE report 12268947 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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