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CONCORDE 187827212Recalls & reported problems

Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM PARALLEL 11 x 12 x 27mm · 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 10705034140018), received between Apr 25, 2018 and Apr 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1
  • Not Applicable1

Recent adverse event reports

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

  • MalfunctionApr 25, 2018Break; Break

    IT WAS REPORTED THE SURGEON WAS PREPARING DEVICE FOR IMPLANTATION AND WHEN HE STRUCK DEVICE WITH A HAMMER, THE DEVICE BROKE IN HALF. ALL PIECES WERE REMOVED AND DEVICE WAS REPLACED. THERE WAS A 3 MINUTE DELAY REPORTED. NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient; Not Applicable

    MAUDE report 7459076 ↗

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