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 · TerminatedCochlear 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
- Baha 92129Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction127 reports
- Baha 92128Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction77 reports
- Baha 92127Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction55 reports
- Baha 90434Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction54 reports
- Baha 5 Sound Processor Tamper-proof battery door 3 pcs P1129017Cochlear Limited · Hearing aid, bone conduction1 recall0 reports
- Baha 92346Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction49 reports
- Baha 92126Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction27 reports
- Baha 92133Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction21 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.