CONCORDE 196923511Recalls & reported problems
Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM LORDOTIC CAGE 9 x 11 x 23mm · Class 2 · Implant
All models of CONCORDE (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034454368), received between Sep 23, 2021 and Sep 23, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2021Migration; Migration
IT WAS REPORTED THAT ON AUGUST 25, 2021, A PATIENT PREVIOUSLY OPERATED WITH RIGHT LEG PAIN. CT IMAGING INDICATED THE CONCORDE BULLET TITANIUM CAGE HAD MIGRATED POSTERIORLY BEYOND THE ENDPLATES RESULTED IN A REVISION SURGERY. THE SURGEON RE-ADVANCED THE CAGE TO THE ANTERIOR ASPECT OF THE DISC SPACE AND ROTATED THE CAGE SUCH THAT THE LONGITUDINAL AXIS OF THE CAGE IS ALIGNED WITH THE CORONAL PLANE USING VARIOUS INSTRUMENTS INCLUDING CONCORDE INSERTER, INSERTER'S STYLET, CONCORDE TAMP, A BONE FUNNEL TAMP, AND DOWNWARD CURETTES. THE SURGEON ALSO LOOSENED THE CONSTRUCT, COMPRESS POSTERIORLY, AND RE-TIGHTEN THE CONSTRUCT TO PREVENT FUTURE MIGRATION OF THE CAGE. CONCOMITANT DEVICE REPORTED: CONCORDE INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). INSERTER'S STYLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). CONCORDE TAMP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). CURETTE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TI CONC BULLET LORD 9X11X23. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Pain
MAUDE report 12519131 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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.
How reports and recalls are matched · Editorial policy · Report an error on this page