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CONCORDE 187823110Recalls & reported problems

Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 x 10 x 23mm · Class 2 · Implant

All models of CONCORDE (24)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10705034139357), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Torn Material” (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

  • Torn Material1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 8, 2018Torn Material; Torn Material

    ON (B)(6) 2018, THE SURGERY FOR LCS WAS PERFORMED BY USING THE CONCORDE SYSTEM. THE FIXED AREA WAS L4 ¿ L5. DUE TO A FAILURE OF THREADS OF THE CONNECTION PART TO THE HOLDER, THE REPORTED DEVICE COULD NOT BE HELD. OTHER IMPLANT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED WITH NO DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7324533 ↗

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Sources and updates

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