Skip to content

CONCORDE 187825211Recalls & reported problems

Medos International Sàrl · CONCORDE INLINE SPINAL SYSTEM PARALLEL IMPLANT 11 x 11 x 25mm, 0 DEGREES · Class 2 · Implant

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 10705034284903), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 injury.

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

  • Failure of Implant1
  • No Code Available1

Recent adverse event reports

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

  • InjuryOct 9, 2020Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING ITS ADJUSTMENT AND POSITIONING, THE DEVICE BROKE AT THE SCREW THREAD. IT WAS DIFFICULT TO RETRIEVE IT. NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE INLINE PAR 11X11X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 10656013 ↗

Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices

All SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices →

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