MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; Cochlear Baha Attract System

Model Number	93550
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Expulsion (2933); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Necrosis (1971); Tissue Breakdown (2681); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced skin breakdown followed by skin necrosis due to excessive magnet strength.Subsequently, the patient developed an infection at the magnet site.The implant magnet was later explanted (date not reported).Additional information has been requested but remains unavailable as of the date of this report.
Additional Manufacturer Narrative
Per the clinic, the patient presented on (b)(6) 2026 with skin necrosis and exposure of the implant magnet.Subsequently, the patient underwent a surgical procedure including exploration, debridement and the implant magnet was explanted on (b)(6) 2026.The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer, and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Adverse skin reactions around the baha, ranging from slight redness to infected tissue, are common complications with baha implants, and can occur at any time following implantation.The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan, and the status is updated on a monthly basis.This event is added to this monitoring.

• Brand Name: BIM400 IMPLANT MAGNET
• Common Device Name: Cochlear Baha Attract System
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): Cochlear Bone Anchored Solutions AB; konstruktionsvägen 14; mölnlycke, västergötland 435 3 3; SW 435 33
• Manufacturer Contact: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25180808
• Report Number: 6000034-2026-01990
• Device Sequence Number: 16128101
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)146982(17)250420
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K131240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/20/2025
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 146982
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 07/22/2026; 08/04/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 08/26/2026; 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female