CONCORDE 187827109Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034139906), received between Jul 23, 2019 and Sep 13, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THREE (3) CONCORDE BUL PARS BROKE. CAGES WERE DEFRAGMENTED DURING THE TRIAL TO PUT THEM IN THE INTERVERTEBRAL SPACE SO THEY WEREN¿T REMOVED AFTER IMPLANTATION. NO CONSEQUENCES FOR THE PATIENT REPORTED. TO COMPLETE THE PROCEDURE THE PHYSICIAN USED ANOTHER ONE TYPE PRODUCT. THERE WAS NO DELAY DURING THE PROCEDURE. THIS REPORT IS FOR ONE (1) CONCORDE BUL PAR 9X9X27. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12462435 ↗
• MalfunctionSep 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THREE (3) CONCORDE BUL PARS BROKE. CAGES WERE DEFRAGMENTED DURING THE TRIAL TO PUT THEM IN THE INTERVERTEBRAL SPACE SO THEY WEREN¿T REMOVED AFTER IMPLANTATION. NO CONSEQUENCES FOR THE PATIENT REPORTED. TO COMPLETE THE PROCEDURE THE PHYSICIAN USED ANOTHER ONE TYPE PRODUCT. THERE WAS NO DELAY DURING THE PROCEDURE. THIS REPORT IS FOR ONE (1) CONCORDE BUL PAR 9X9X27. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12462394 ↗
• MalfunctionDec 31, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE CAGE CRASHED FROM THE BOTTOM SIDE. THIS REPORT IS FOR ONE CARBON-FIBER COMPOSITE, PARALLEL, 0°, 9X9X27MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535558 ↗
• MalfunctionJul 23, 2019Break; Break

  PRODUCT HAS BEEN BROKEN DURING PROCEDURE. MORE DETAIL SEE ON PICTURES. NO CONSEQUENCES FOR THE PATIENT. TO PROCEDURE COMPLETED PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8815672 ↗