CONCORDE 187823107Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034139326), received between Apr 16, 2018 and Dec 30, 2022 — classified as 3 injuries, 2 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.

• InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLIF ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON DECEMBER 16, 2022, AN EXTENSION TO THE UPPER VERTEBRAL BODY REVISION PLIF WAS SCHEDULED TO BE PERFORMED BECAUSE THE PATIENT DEVELOPED AN ADJACENT INTERVERTEBRAL DISORDER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 7 X 23MM. THIS IS REPORT 10 OF 12 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16078340 ↗
• InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLIF ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON (B)(6) 2022, AN EXTENSION TO THE UPPER VERTEBRAL BODY REVISION PLIF WAS SCHEDULED TO BE PERFORMED BECAUSE THE PATIENT DEVELOPED AN ADJACENT INTERVERTEBRAL DISORDER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 7 X 23MM. THIS IS REPORT 11 OF 12 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16078338 ↗
• MalfunctionAug 12, 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 A SURGERY FOR PLIF. DURING THE SURGERY, THE CAGE WAS BROKE DUE TO A LIMITED INTERBODY SPACE WHEN THE CAGE WAS TAPPED WITH A HAMMER. THE SURGERY WAS COMPLETED WITHOUT DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CONCORDE BUL PAR 9X7X23. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314230 ↗
• 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 THE SURGEON APPLIED A DURAL PATCH.

  Patient problems: No Code Available; Spinal Cord Injury

  MAUDE report 8599169 ↗
• MalfunctionApr 16, 2018Break; Break

  IT WAS REPORTED DEVICES BROKE INTRA-OP. ALL BROKEN PIECES WERE RETRIEVED. SURGEON COMPLETED PROCEDURE WITH MINOR DELAY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7432652 ↗