CONCORDE 287901000Recalls & reported problems
Depuy Spine, LLC · CONCORDE SYSTEM INSERTER, STRAIGHT · Class 1
All models of CONCORDE (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034219882), received between Nov 15, 2021 and Sep 7, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
Device problems
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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