CONCORDERecalls & reported problems across all models

We found 24 models of CONCORDE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Jan 13, 2025 — classified as 21 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CONCORDE problems

CONCORDE models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CONCORDE 187827408

  Intervertebral fusion device with bone graft, lumbar
  8 reports
• CONCORDE 187823107

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  5 reports
• CONCORDE 187823108

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  5 reports
• CONCORDE 187823109

  Intervertebral fusion device with bone graft, lumbar
  5 reports
• CONCORDE 187827109

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  4 reports
• CONCORDE 187823408

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• CONCORDE 187827512

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  3 reports
• CONCORDE 187827107

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  2 reports
• CONCORDE 187827111

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CONCORDE 187827409

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CONCORDE 187850209

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  2 reports
• CONCORDE 187823110

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CONCORDE 187823111

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• CONCORDE 187823410

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CONCORDE 187827110

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CONCORDE 187827212

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• CONCORDE 187827410

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• CONCORDE 187827411

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CONCORDE 187831209

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CONCORDE 187850208

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CONCORDE 187825211

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• CONCORDE 196923511

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CONCORDE 196927519

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• CONCORDE 196923011

  Intervertebral fusion device with bone graft, lumbar
  1 report

Recent CONCORDE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA PHONE TODAY. UPON CONTACT WITH THE HOSPITAL, THE PATIENT HAD LOWER EXTREMITY PAIN AFTER LUMBAR FUSION SURGERY, AND WAS UNABLE TO WALK INDEPENDENTLY WHEN THE SYMPTOMS WORSENED (SPECIFIC EVENT DATE COULD NOT BE VERIFIED), AND THE HOSPITAL DID NOT PROVIDE MORE DETAILS ABOUT THE EVENT.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 21139713 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE LUMBAR FUSION SURGERY, THE PRODUCT WAS IMPLANTED INTO THE PATIENT. FOUR YEARS LATER, THE PATIENT DEVELOPED LEFT LOWER EXTREMITY PAIN AND INABILITY TO WALK INDEPENDENTLY. IT WAS SUSPECTED THAT THE INFECTION OCCURRED AFTER IMPLANTATION OF THE PRODUCT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 21139708 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE LUMBAR FUSION SURGERY, THE PRODUCT WAS IMPLANTED INTO THE PATIENT. FOUR YEARS LATER, THE PATIENT DEVELOPED LEFT LOWER EXTREMITY PAIN AND INABILITY TO WALK INDEPENDENTLY. IT WAS SUSPECTED THAT THE INFECTION OCCURRED AFTER IMPLANTATION OF THE PRODUCT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 21139707 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE CONCORDE BROKE. SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS THAT WERE GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136525 ↗
• MalfunctionJan 13, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING SURGERY, THE CONCORDE BROKE. SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS THAT WERE GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136524 ↗
• MalfunctionOct 18, 2024Break; Break

  IT WAS REPORTED THAT BEFORE THE SURGERY ON (B)(6) 2021, DURING DISINFECTION THE DEVICE WAS FOUND TO BE CRACKED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486265 ↗
• 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 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: THE PATIENT HAD A POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AT AN UNKNOWN DATE AFTER THE SURGERY, ASD OCCURRED. IT WAS REPORTED THAT ON (B)(6) 2023, A REVISION PROCEDURE WAS PERFORMED TO EXTEND FIXATION. OLIF WAS PERFORMED IN L2/3 AND L3/4 IN SIDE LYING POSITION. A POSITIONAL CHANGE TO PRONE AND REMOVAL OF EXISTING 4/5 CROSSLINK, SET SCREW AND ROD. PLIF FOR L5/S (USING NON-DEPUY SYNTHES PRODUCT). VERSE SCREW INSERTION AT L2 (DIAMETER 6.0 - LENGTH 45MM), VERSE SCREW INSERTION AT L3 (DIAMETER 7.0 - 45MM). EXPEDIUM-CFS INSERTION IN S1 (DIAMETER 7.0 - LENGTH 40MM), EXPEDIUM-CFS INSERTION IN S2 ALLER (DIAMETER 7.0 - 40MM) OSTEOTOMY ROD INSTALLATION SET SCREW CORRECTION BONE GRAFT FINAL TIGHTENING CROSS-LINK INSTALLATION THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 8 X 23MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18049947 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: THE PATIENT HAD A POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AT AN UNKNOWN DATE AFTER THE SURGERY, ASD OCCURRED. IT WAS REPORTED THAT ON (B)(6) 2023, A REVISION PROCEDURE WAS PERFORMED TO EXTEND FIXATION. - OLIF WAS PERFORMED IN L2/3 AND L3/4 IN SIDE LYING POSITION. - A POSITIONAL CHANGE TO PRONE AND REMOVAL OF EXISTING 4/5 CROSSLINK, SET SCREW AND ROD. - PLIF FOR L5/S (USING NON-DEPUY SYNTHES PRODUCT). - VERSE SCREW INSERTION AT L2 (DIAMETER 6.0 - LENGTH 45MM), VERSE SCREW INSERTION AT L3 (DIAMETER 7.0 - 45MM). - EXPEDIUM-CFS INSERTION IN S1 (DIAMETER 7.0 - LENGTH 40MM), EXPEDIUM-CFS INSERTION IN S2 ALLER (DIAMETER 7.0 - 40MM). - OSTEOTOMY ROD INSTALLATION SET SCREW CORRECTION. - BONE GRAFT FINAL TIGHTENING. - CROSS-LINK INSTALLATION. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 8 X 23MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18049944 ↗
• InjuryOct 3, 2023Adverse 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6) 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THIS REPORT INVOLVES ONE CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 11 X 27MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS DIFFICULTIES ENCOUNTERED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE RODS INVOLVED IN THE EVENT. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17862115 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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