Skip to content

CONCORDE 187831209Recalls & reported problems

Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM PARALLEL 11 x 9 x 31mm · 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 10705034140537), received between Jan 4, 2021 and Jan 4, 2021 — 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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 4, 2021Break; Break

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE IMPLANT BROKE DURING INSERTION. CONCOMITANT DEVICE: UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) CONCORDE BULLET SPINAL SYSTEM PARALLEL 11 X 9 X 31MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11108589 ↗

Other Intervertebral fusion device with bone graft, lumbar devices

All Intervertebral fusion device with bone graft, lumbar devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page