CONCORDE 187823410Recalls & reported problems
Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM LORDOTIC 9 x 10 x 23mm, 5 DEGREES · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034139517), received between Apr 10, 2018 and Apr 10, 2018 — classified as 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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2018Break; Break
IT WAS REPORTED THE SURGEON WAS TRYING TO PLACE A CAGE AT L5-S1 DISC SPACE. HE WAS COMING IN LATERALLY THEN PULLED HIS HAND DOWN WITH INSERTER TO DRIVE THE CAGE TO A MORE MIDLINE APPROACH AND THE CAGE BROKE OFF AT THE INSTRUMENT/CAGE INTERFACE. THIS HAPPENED WITH BOTH CAGES. THEN PROCEEDED TO USE THE DUAL PREP INSTRUMENT TO GET MORE MIDLINE AND THEN THE THIRD CAGE WAS PLACED TO HIS SATISFACTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7411969 ↗
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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
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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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