CONCORDE 187823108Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034139333), received between Apr 16, 2018 and Nov 1, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• 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 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5) PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM ASD BETWEEN L3-4. THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE (L3-4 PLIF EXTENSION) ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 8 X 23MM. THIS IS REPORT 12 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 13177314 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5) PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM ASD BETWEEN L3-4. THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE (L3-4 PLIF EXTENSION) ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 8 X 23MM. THIS IS REPORT 7 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 13177306 ↗
• 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 7432674 ↗