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CONCORDE 187823111Recalls & reported problems

Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 x 11 x 23mm · 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 10705034139364), received between Jul 28, 2017 and Jul 28, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJul 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    ON (B)(6) 2017, THE SURGERY FOR DEGENERATIVE LUMBAR SPONDYLOLISTHESIS WAS PERFORMED USING THE CONCORDE SYSTEM. THE FIXED AREA IS L4-L5. IN (B)(6), THE SURGEON CONFIRMED UNDER AN X-RAY THAT THE REPORTED PRODUCT (PART#:1878-23-108 / CONC BULLET PARALLEL 9X8X23) WAS BACKED OUT. ALTHOUGH THE PRODUCT IN QUESTION IS SITTING BETWEEN THE SPINAL CANAL, THE PATIENT CURRENTLY HAS NO SYMPTOMS. THE PATIENT HAS BEEN UNDER MONITORING AS IT IS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE HOSPITAL.

    Patient problems: Failure of Implant

    MAUDE report 6751173 ↗

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