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CONCORDE LIFT 2878-80-117Recalls & reported problems

Medos International Sàrl · CONCORDE LIFT INSTRUMENTS CAGE INSERTER TETHER · Class 2

All models of CONCORDE LIFT (13)

Data updated Oct 18, 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 10705034507316), received between May 30, 2018 and May 30, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1
  • Detachment Of Device Component1

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.

  • MalfunctionMay 30, 2018Break; Detachment Of Device Component

    SURGEON SHEARED OFF THE END OF THE TORQUE DRIVER WHEN TORQUEING OUT THE CONCORDE LIFT IMPLANT. AFTER INSERTION THE SURGEON IMPACTED THE IMPLANT INTO THE L4/5 DISC SPACE. WITH THE IMPLANT INSERTION DEVICE ON THE SURGEON THEN TRIED TO EXPAND THE DEVICE. THEN HE REMOVED THE INSERTION DEVICE AND TRIED TO FINAL TORQUE THE IMPLANT WITHOUT THE IMPLANT HOLDER ON AND THE DRIVER TIP BROKE OFF WITHOUT TORQUEING OUT. THE SURGEON THEN SUCTIONED OUT THE BROKEN END OF THE TIP, AND LEFT THE IMPLANT IN THE SPACE AND COMPRESSED ON THE SCREWS ABOVE AND BELOW. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7554407 ↗

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Sources and updates

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