CONCORDE 187850209Recalls & reported problems
Medos International Sàrl · CONCORDE INLINE SPINAL SYSTEM LORDOTIC IMPLANT STRAIGHT 9 x 9 x 25mm, 5 DEGREES · Class 2 · Implant
- 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 10705034141565), received between Jan 13, 2025 and Jan 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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, 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
- Break2
- No Apparent Adverse Event1
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.
MalfunctionJan 13, 2025Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE CONCORDE BROKE. SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS THAT WERE GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21136525 ↗MalfunctionJan 13, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT DURING SURGERY, THE CONCORDE BROKE. SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS THAT WERE GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21136524 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.