SP Magnet 2 95772Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09321502028707), received between Feb 7, 2018 and Feb 7, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Extrusion” (1 report).

1 other recall cover devices cleared under the same FDA submission (K131240); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2018Extrusion; Extrusion

  PER THE SURGEON, THE PATIENT EXPERIENCED EXTRUSION OF THE MAGNET AND SUBSEQUENTLY WAS TREATED WITH AN ORAL ANTIBIOTIC (DATE AND DURATION NOT REPORTED). ON (B)(6) 2018 THE PATIENT UNDERWENT A SKIN REVISION UNDER A GENERAL ANAESTHETIC. THERE ARE PLANS TO RESUME USE OF THE DEVICE ONCE THE SITE HAS HEALED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7246792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131240. One submission often covers many models, so check the product and lot details in each record.

• Z-1699-2014 · Apr 9, 2014 · Terminated
  Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.