CONCORDE 287901009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034219899), received between May 10, 2019 and Sep 17, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INTERNAL THREADING OF THE CONCORDE BULLET INSERTER WILL NOT PROPERLY SECURE TO THE END OF THE CONCORDE BULLET CAGE. THE SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073369 ↗
• MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE POSTERIOR LUMBAR INTERBODY FUSION (PLIF) FOR THE DEGENERATIVE DISEASE WITH THE CAGE (PROTI-CONCORDE CAGE) IN QUESTION. BOTH THE NURSE AND THE SURGEON COULD NOT GRASP IT VERTICALLY WITH THE INSERTER. THERE WAS NO PROBLEM WITH THE HANDLING OF THE CAGE AND INSERTER. THEY USED A NEW CAGE AND WAS ABLE TO BE GRASPED VERTICALLY WITH THE INSERTER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CONCORDE INSERTER-BAYONET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080521 ↗
• MalfunctionJun 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGICAL PROCEDURE. DURING THE PROCEDURE, WHEN ATTEMPTING TO ROTATE THE CAGE, THE INSTRUMENT FRACTURED. ANOTHER CAGE SYSTEM WAS USED, AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, NO SURGICAL DELAY WAS REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CONCORDE INSERTER-BAYONET. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929792 ↗
• MalfunctionNov 25, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A L4-S1 POSTERIOR LUMBER INTERBODY FUSION ON PATIENT ON (B)(6) 2019. DURING PROCEDURE SURGEON CLEARED THE L4-5 DISC SPACE AND INSERTED TWO (2) 11X13X27 FIVE DEGREE CONCORDE CAGE OF WHICH HE REMOVED ONE WHICH WAS STILL ON THE INSERTER AND ATTEMPTED TO REMOVE THE SECOND CAGE BUT WAS UNABLE TO DO SO, INSTEAD HE TAMPED THIS CAGE FARTHER IN. MORE DISC MATERIAL WAS REMOVED ON ONE SIDE AND THEN THE REMOVED 11X13X27 FIVE DEGREE CAGE WAS REINSERTED. HOWEVER THE INSERTER SNAPPED OFF THE CAGE AND THE SURGEON HAD TO REMOVE A BLACK RING FROM WHERE THE CAGE CONNECTED TO THE INSERTER AND PART OF THE BACKSIDE OF THE CAGE WHICH HAD BROKEN OFF INTO THE PATIENT. SURGEON DID NOT WANT TO REMOVE THIS CAGE AND CONFIRMED THAT HE WAS HAPPY WITH THE POSITIONING OF THE CAGES AFTER IMAGE INTENSIFIER WAS TAKEN. FRAGMENTS WERE GENERATED, BUT WERE REMOVED EASILY. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME IS UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370810 ↗
• InjuryMay 10, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THE SURGEON WAS ATTEMPTING TO INSERT A 9X7X23MM CONCORDE CAGE INTO A COLLAPSED DISC SPACE AT THE L1-L2 LEVEL. DURING IMPACTION, THE IMPLANT COME OFF THE INSERTER AND THE INSERTER CONCUSSED THE CORD. AT THAT POINT, THE SURGEON DEFAULTED ON THE INTERBODY. THE CASE WAS COMPLETED WITHOUT ISSUES. THE PATIENT HAS SHOWN NO SIGNS OF DEFICIT OR INJURY. THE SURGEON WOULD LIKE TO WHY THE INSERTER DISENGAGED FROM THE CAGE. IT WAS ALSO REPORTED THAT A DURAL PATCH WAS APPLIED.

  Patient problems: No Code Available; Spinal Cord Injury

  MAUDE report 8599313 ↗