Skip to content

SP Magnet 6 95776Recalls & reported problems

Cochlear Bone Anchored Solutions AB · Class 2

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 09321502028660), received between Aug 15, 2018 and Aug 15, 2018 — classified as 1 injury.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Discomfort1

Recent adverse event reports

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

  • InjuryAug 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER THE AUDIOLOGIST, IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH A TOPICAL ANTIBIOTIC (DATE NOT REPORTED).

    Patient problems: Discomfort

    MAUDE report 7783929 ↗

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.

Other Hearing aid, bone conduction devices

All Hearing aid, bone conduction devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.