CONCORDE 187827408Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034140056), received between Oct 22, 2017 and Feb 5, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED THE IMPLANT BROKE INTO PIECES DURING THE PROCEDURE ON (B)(6) 2024. NO CONSEQUENCES FOR THE PATIENT REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER PRODUCT THE SAME TYPE. THIS REPORT IS FOR ONE CONCORDE BULLET SPINAL SYSTEM LORDOTIC IMPLANT 9 X 8 X 27MM, 5 DEGREES FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646263 ↗
• MalfunctionNov 15, 2023Break; Break

  DEVICE REPORT FROM MALAYSIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON 26-OCTOBER-2023, THE CONCORDE BULLET IN QUESTION HAD ITS CORNER BREAK OFF DURING IMPLANTATION. DURING THE IMPLANTATION PROCESS, THE BACK CORNER BROKE OFF WHILE BEING IMPACTED INTO THE PATIENT BODY USING A MALLET. THE BROKEN IMPLANT WAS REMOVED AND REPLACED WITH A NEW IMPLANT. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 10 MINUTES OF SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A CONCORDE BULLET SPINAL SYSTEM LORDOTIC IMPLANT 9 X 8 X 27MM, 5 DEGREES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140895 ↗
• MalfunctionJul 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT AFTER INITIAL PLACEMENT OF THE CAGE THE POSITION HAD TO BE CHANGED AGAIN AND DURING REMOVAL THE CAGE FRACTURED INTO TWO PARTS. IT IS UNCLEAR WHETHER THE CAGE ALREADY FRACTURED DURING INSERTION. NO SURGICAL DELAY, NO PATIENT HARM REPORTED. NO FRAGMENT REMAINED IN PATIENT´S BODY. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) CONCORDE BUL LOR 9X8X27, 5 DG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121614 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT THE SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX L5/S. DURING THE SURGERY, THE SURGEON CORRECTED THE CAGE POSITION BECAUSE THE CAGE POSITION WAS SIFTED. THEN, IT WAS REPORTED THE SURGEON RECOGNIZED THAT THE CAGE WAS BROKEN (SMALL CRACK) WHEN THE SURGEON REMOVED THE SIFTED CAGE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254303 ↗
• MalfunctionJun 14, 2018Break; Break

  ON (B)(6) 2018, THE TLIF SURGERY FOR SPINAL CANAL STENOSIS WAS PERFORMED BY USING THE CONCORDE BULLET. THE FIXED AREA WAS L5-S1 DURING THE SURGERY, THE FOLLOWING EVENT WAS CONFIRMED BY THE SURGEON. AFTER ATTACHING THE CAGE (187827408, LOT#: 159462) TO AN INSERTER (PART#: UNKNOWN), THE SURGEON TRIED TO INSERT THE CAGE BY IMPACTING THE INSERTER WITH A HAMMER (PART#: UNKNOWN). WHILE ADJUSTING THE INSERTION ANGLE OF THE CAGE, THE INSERTER COME OFF THE CAGE. THEN, IT WAS FOUND THAT THE CAGE WAS BROKEN, THUS HE WAS UNABLE TO HOLD IT WITH THE INSERTER. HE EXTRACTED THE BROKEN CAGE BY USING A PLIER AND THEN INSERTED ANOTHER NEW CAGE. NO BROKEN PIECES WERE FOUND LEFT IN THE PATIENT¿S BODY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

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

  MAUDE report 7600867 ↗
• MalfunctionMar 5, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SPINAL SURGERY ON (B)(6) 2018, THE CONCORDE BULLET SPINAL SYSTEM LORDOTIC IMPLANT 9 X 8 X 27MM, 5 DEGREES, BROKE AFTER STRIKING IT TO INSERT IT. THE FIXED AREA WAS UNKNOWN. THE SURGERY WAS COMPLETED WITH A TWENTY-MINUTE (20) DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Not Applicable

  MAUDE report 7314225 ↗
• MalfunctionDec 20, 2017Break; Material Fragmentation; Break; Material Fragmentation

  WHEN ATTEMPTING TO IMPLANT A CONCORDE BULLET INTERBODY FUSION CAGE, THE CAGE BROKE INTO SEVERAL PIECES. THE PIECES WERE RETRIEVED AND WILL BE SENT BACK TO THE HEAD OFFICE PATIENT CONSEQUENCE? :NO. ACTION TAKEN FOR PROCEDURE:COMPLETED WITH ANOTHER CONCORDE BULLET INTERBODY FUSION CAGE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133002 ↗
• MalfunctionOct 22, 2017Break; Break

  ON (B)(6) 2017, TLIF SURGERY WAS PERFORMED USING THE CONCORDE SYSTEM IN COMBINATION WITH X-TAB. THE FIXED ARE WAS L3-L4. ON (B)(6) 2017, DUE TO POSTOPERATIVE INFECTIONS, THE SURGEON REMOVED THE SCREWS AT L3-L4 AND THEN MADE NEW FIXATION AT L1/L2/L5/S. IN ADDITION, AS THE SURGEON TRIED TO REMOVE THE CAGE (PART#: 187827408, LOT#: APKB5K) FROM PATIENT, THE CAGE (PART#: 187827408, LOT#: APKB5K) GOT BROKEN AND THEN THE BROKEN PART WAS LEFT IN THE PATIENT¿S BODY. THE REMOVAL AND NEW FIXATION OPERATION WAS COMPLETED WITH A 10-MINUTE DELAY. NO FURTHER INFORMATION HAS BEEN PROVIDED FROM THE HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6967863 ↗