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CONCORDE® ProTi 360°™ 188823110Recalls & reported problems

Tyber Medical, LLC · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917020779), received between Dec 10, 2020 and Dec 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

Most reported problems

Device problems

  • Migration1

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.

  • MalfunctionDec 10, 2020Migration; Migration

    "IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A CONCORDE BULLET PROTI CAGE MIGRATE POSTERIORLY OUT OF THE DISC SPACE. THERE WAS AN UNKNOWN PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. PLANNED REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020. THIS COMPLAINT INVOLVES ONE (1) DEVICE."

    Patient problems: Insufficient Information

    MAUDE report 10982996 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.