CONCORDE® ProTi 360°™ 188823408Recalls & 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 00819917020922), received between Jun 28, 2022 and Jun 28, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- Cardiovascular Dysfunction/Insufficiency1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2022Use of Device Problem; Use of Device Problem
ON AN UNKNOWN DATE THE PATIENT UNDERWENT A PRIMARY PROCEDURE AT A DIFFERENT HOSPITAL. ON (B)(6) 2022 THE PATIENT UNDERWENT A PLIF REVISION PROCEDURE (L3/4/5). THE SURGEON TOOK THE FOLLOWING STEPS. 2,000 CC OF HEMORRHAGE WAS RECORDED DURING DECOMPRESSION. ENSUING PROCEDURES UP TO DEPLOYING A CAGE WAS PERFORMED WITHOUT AN ISSUE. AFTER THE CAGE WAS DEPLOYED, 3,500 CC OF HEMORRHAGE WAS RECORDED. WHILE THEY WERE TAKING A MEASURE TO STOP THE HEMORRHAGE, THE PATIENT WENT INTO CARDIOPULMONARY ARREST. THEY CLOSED THE INCISION AND STOPPED FURTHER SPINE PROCEDURE. THE ANESTHETIC TEAM TOOK A RESUSCITATION TREATMENT, AND AN ELECTROCARDIOGRAM SHOWED A RESUSCITATED CARDIAC STATUS. THE PROCEDURE WAS DELAYED BY MORE THAN 30 MINUTES. THE SURGEON COMMENTED THE FOLLOWING: THE PATIENT HAS BEEN SUPPORTED BY A CARDIAC PACEMAKER DUE TO IRREGULAR PULSE. THE SPINE REVISION WILL BE RESCHEDULED. IT WAS NOT CONFIRMED IF THE IMPLANTS MIGHT HAVE TRIGGERED THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.
Patient problems: Cardiovascular Dysfunction/Insufficiency; Hemorrhage/Blood Loss/Bleeding
MAUDE report 14846837 ↗
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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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