Sophysa SM8A-2010Recalls & reported problems
Sophysa · SOPHY SM8A KIT PREATTACHED/BO19-10 · Class 2 · Implant
Data updated Oct 13, 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 03760124131222), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (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
- Inappropriate or Unexpected Reset1
Patient problems
- Hydrocephalus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
AFTER THE MRI EXAM, THE PATIENT BEGAN TO HAVE HEALTH PROBLEMS SUCH AS SYMPTOMS OF HYDROCEPHALUS AND SEVERE DISORDERS. THE DOCTOR OBSERVED THAT THE VALVE WAS DEPROGRAMMED AND HAD CAUSED HYPERDRAINAGE. THE DOCTOR TRIED TO ADJUST THE VALVE, BUT THE IDEAL ADJUSTMENT WAS NO LONGER ACHIEVABLE, EITHER LEADING TO OVERDRAINAGE OR DILATED VENTRICLES. THE DOCTOR DECIDED TO EXPLANT THE VALVE AND REPLACE IT WITH ANOTHER ONE. DATE OF IMPLATANTION: (B)(6) 2024. DATE OF FIRST MRI EXAM: (B)(6) 2024. DATE OF EXPLANTATION: (B)(6) 2024.
Patient problems: Hydrocephalus
MAUDE report 21371940 ↗
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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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