CONCORDE® ProTi 360°™ 188827408Recalls & reported problems
Tyber Medical, LLC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917021288), received between Jul 18, 2023 and Feb 22, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 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: 6-WEEK AND 11-MONTH RADIOGRAPHS DETAIL SUBSIDENCE (>2.5 MM) CRANIAL. THE 11-MONTH POST-OPERATIVE RADIOGRAPHS DETAIL THE SUBSIDENCE IS ONLY REGARDING THE ANTERIOR ASPECT OF THE CAGE. PATIENT FUSED AT 11 MONTHS POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21440452 ↗InjuryJul 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THIS WAS A PLIF (L5/S1) FOR SPINAL STENOSIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, IN (B)(6) 2023, A REVISION SURGERY DUE TO NON-UNION WILL BE PERFORMED. IN THE REVISION SURGERY, THE CAGES IN QUESTION WILL BE REMOVED AND REPLACED WITH DIFFERENT SIZED CAGES. CAUSES OF THE EVENT ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.
Patient problems: Insufficient Information
MAUDE report 17342308 ↗
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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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