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CONCORDE 187827411Recalls & reported problems

Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM LORDOTIC 9 x 11 x 27mm, 5 DEGREES · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034140087), received between Jul 30, 2018 and Jul 30, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

  • Material Split, Cut or Torn1

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.

  • InjuryJul 30, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

    DURING THE SURGERY PERFORMED ON (B)(4) 2018, IT WAS FOUND THAT THE CONCORDE BULLET ((B)(4)) GOT BROKEN AT THE SITE WHERE THE INSERTOR WAS ATTACHED AND RESULTED IN AN UNSUCCESSFUL INSERTION. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7731347 ↗

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Sources and updates

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