CONCORDE 187827512Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034140193), received between Oct 22, 2017 and Dec 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT THE CAGE CRACKED. WHEN THE PATIENT UNDERWENT THE SURGERY OF POSTERIOR LUMBAR DECOMPRESSION AND FUSION, IT WAS SEPARATED TWO TIMES TO COMPLETE THE SURGERY. THE CAGE WAS IMPLANTED ON (B)(6) 2022 AND THE SCREWS WERE IMPLANTED ON (B)(6) 2022. DURING THE SURGERY OF SCREW IMPLANTED ON (B)(6) 2022, IT WAS FOUND THAT THE CAGE WAS CRACKED. THEN ANOTHER NEW CAGE WAS USED TO REPLACE THE CRACKED ONE TO COMPLETE THE SURGERY. NO VISIBLE DEBRIS IS GENERATED, THE CONCORDE MIXER IS REMOVED DIRECTLY AND THERE IS NO OTHER DEBRIS DISPOSAL THE PATIENT WAS IN STABLE CONDITION NOW. THIS REPORT IS FOR ONE (1) CONCORDE BUL LOR 11X12X27 5 DG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958930 ↗
• MalfunctionSep 22, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY OF OPEN REDUCTION AND INTERVERTEBRAL FUSION WITH PEDICLE SCREW FIXATION FOR LUMBAR SPONDYLOLYSIS, WHEN INSERT THE DEVICE, THE DEVICE WAS CRACKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CONCORDE BUL LOR 11X12X27 5 DG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10569998 ↗
• MalfunctionOct 22, 2017Break; Break

  SURGEON WAS INSERTING THE CONCORDE BULLET CAGE IN BETWEEN VERTEBRA BODY WITH MALLET KNOCKED ON THE TOP NOTCH OF CAGE INSERTER SEVERAL TIMES UNTIL IT FLUSHED. HOWEVER, WHEN SURGEON DETACHED THE INSERTER FROM THE CAGE AND HE FOUNDS OUT THE CAGE WAS BROKE INTO HALF INSIDE PATIENT BODY. THE CAGE WAS UNABLE TO TAKE OUT AS IT WAS DIFFICULT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6967869 ↗