CONCORDERecalls & reported problems across all models
Depuy Spine, LLC · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 9 models of CONCORDE by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between May 10, 2019 and Sep 17, 2025 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Break” (17 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
Reports received per month, all models
Most reported CONCORDE problems
Device problems
- Break17
- Device-Device Incompatibility3
- Contamination /Decontamination Problem1
- Crack1
- Material Deformation1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient4
- Insufficient Information1
- No Code Available1
- Spinal Cord Injury1
CONCORDE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONCORDE 287908008ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- CONCORDE 287901009DRIVER, PROSTHESIS5 reports
- CONCORDE 287901000DRIVER, PROSTHESIS2 reports
- CONCORDE 287902000IMPACTOR2 reports
- CONCORDE 287804013TEMPLATE1 report
- CONCORDE 287903001RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- CONCORDE 287903003RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- CONCORDE 292952490RONGEUR1 report
- CONCORDE 292954602RONGEUR1 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.
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 ↗MalfunctionMar 7, 2025Break; Break
IT WAS REPORTED THAT THE TAPS BECAME BLUNT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21553129 ↗MalfunctionMar 7, 2025Break; Break
IT WAS REPORTED THAT THE TAPS BECAME BLUNT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21553110 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A THORACOLUMBAR POSTERIOR FUSION (L4/ L5) FOR ADULT SPINAL DEFORMITY ON (B)(6)2024. IN THE SURGERY, DURING USE OF THE BONE FUNNEL IN QUESTION, WHEN THE UPPER PART OF THE OUTER TUBE WAS STRUCK SEVERAL TIMES WITH A MEDICAL HAMMER (PLASTIC) WHILE THE INNER TUBE PART WAS REMOVED, AN UNUSUAL NOISE WAS HEARD AND THE WELDING PART BETWEEN THE BONE SUPPORT PART OF THE UPPER PART OF THE OUTER TUBE AND THE 8 MM OUTER TUBE PART DISINTEGRATED. THE USE WAS DISCONTINUED IMMEDIATELY AND BONE GRAFTING WAS PERFORMED BY ANOTHER METHOD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE CONCORDE SYSTEM BONE FUNNEL 8MM THIS IS REPORT 1 OF 1 FOR(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720245 ↗MalfunctionMay 20, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE INSTRUMENT BROKE INTRA-OPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE CONCORDE BULLET SPINAL SYSTEM TRIAL 9 X 13MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19352910 ↗MalfunctionMar 5, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS BREAKAGE. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR ONE (1) CONCORDE RASP STR BAYNT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836316 ↗MalfunctionJul 6, 2023Crack; Material Deformation; Crack; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PLASTIC ON PUSHER WAS CRACKED. NO OTHER INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) CONCORDE BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17267594 ↗MalfunctionMay 5, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ANGLED RASP HANDLE WAS BROKEN, THE BLADE HOLDER MECHANISM WAS STUCK, AND THE PROBE THREADS WERE WORN OUT, AND THE X25 INSERTER TIP WAS BENT. THERE WAS NO EXTENSION OF SURGERY TIME AND NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCTS. THIS REPORT INVOLVES ONE CONCORDE SYSTEM RASP, RIGHT ANGLE. THIS REPORT IS RELATED TO (B)(4). THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16875349 ↗MalfunctionApr 18, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF (L4/5) FOR LSCS ON (B)(6) 2023. A CAGE WAS INSERTED USING AN INSERTER. THE HANDLE OF THE MPACTOR BROKE WHEN THE IMPACTOR USED AT THE FINAL STAGE OF INSERTION. THE BREAKAGE OCCURRED OUT OF THE SURGICAL FIELD, AND BROKEN FRAGMENTS SEEMED NOT TO BE IN THE PATIENT¿S BODY, BUT THE SURGEON WASHED THE AFFECTED SITE JUST TO BE SURE. THE SURGEON CONFIRMED THAT THERE WAS NOTHING LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CONCORDE IMPCTR STRGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16765236 ↗MalfunctionSep 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND IN HOLLOW PART OF THE INSERTER IN QUESTION DURING PREOPERATIVE CLEANSING ON (B)(6) 2022. THE INSERTER WAS CLEANED AND STERILIZED ALREADY AT THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONCORDE SYSTEM INSERTER, STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15368717 ↗MalfunctionMar 1, 2022Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A SPINAL FUSION (L4/5) FOR TREATING LUMBAR SPINAL CANAL STENOSIS ON, WHEN THE SURGEON TAPPED THE FUNNEL WITH A PLASTIC HAMMER, IT CAUSED THE COMPONENT IN THE TRIANGULAR PYRAMID SHAPE TO BREAK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THE PATIENT HAD NO ADVERSE EFFECT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE BONE FUNNEL 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636045 ↗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 ↗MalfunctionNov 15, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THIS WAS A LUMBAR INTERBODY FUSION (L2/3) FOR THE SPONDYLOLISTHESIS (B)(6) 2021. THE CONCORDE SYSTEM INSERTED COULD NOT GRASP THE CONCORDE CAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER CAGE AND WAS ABLE TO GRASP IT WITH THE INSERTER WITHOUT ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE SYSTEM INSERTER, STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12815711 ↗MalfunctionNov 15, 2021Break; Break
LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2021, THE CONCORDE IMPACTOR STRAIGHT WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT THIRD PARTY SERVICER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE IMPACTOR STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12814985 ↗MalfunctionNov 15, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE KERRISON DID NOT PUNCH CORRECTLY. THIS REPORT IS FOR ONE (1) LAT 4MM 90 DEG KERRISON RNGUER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12814869 ↗
Other Depuy Spine, LLC products
All Depuy Spine, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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