CONCORDE 187827111Recalls & reported problems
Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 x 11 x 27mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034139920), received between Jun 29, 2017 and Oct 3, 2023 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Consequences Or Impact To Patient1
- Osteolysis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJun 29, 2017Break; Break
THE DEVICE HAS BROKEN DURING SURGERY IN THE PATIENT. DEVICE REMOVED AND REPLACED WITH ANOTHER CAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6676351 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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