FlexBand 31051Recalls & reported problems
Artelon · Dynamic Matrix · 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 00868047000335), received between Dec 16, 2024 and Dec 16, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2024Break; Break
IT WAS REPORTED THAT THE SURGEON RE-OPERATED ON A FEMALE PATIENT 18 MONTHS AFTER A RIGHT PERONEUS BREVIS REPAIR. UPON REOPERATION THE SURGEON NOTICED THE DEVICE WAS BROKEN IN HALF IN THE MIDDLE. THE SURGEON SAID SHE WAS DOING GREAT OVER A YEAR AND A HALF ANOTHER ANKLE SPRAIN LIKELY TEARING THE BAND AT THAT TIME.
Patient problems: Insufficient Information
MAUDE report 20946899 ↗
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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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