MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93331
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Transient pain is a known medical complication where most cases can be resolved with clinical case management.Known reasons for cause of pain are abnormal skin sensitivity, earlier trauma to the implanted area, lack of adequate bone quality or other generalized diseases.It might also be due to a loose implant magnet, causing pain around the implanted area when using the baha sound processor.Adverse skin reactions around the baha abutment, 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.
Event or Problem Description
Per the clinic, the patient experienced pain and infection.Subsequently, the patient underwent abutment removal procedure on (b)(6) 2026 and new abutment was placed during the same procedure.Additional information has been requested but has not been made available as of the date of this report.
Additional Manufacturer Narrative
Correction: the initial mdr submitted on march 17, 2026, was filed inadvertently.The patient only experienced pain, skin overgrowth and skin irritation over the abutment but no infection reported which leads to abutment replacement procedure on (b)(6) 2026.The internal fixture remains.No serious injury has occurred.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.Transient pain is a known medical complication where most cases can be resolved with clinical case management.Known reasons for cause of pain are abnormal skin sensitivity, earlier trauma to the implanted area, lack of adequate bone quality or other generalized diseases.It might also be due to a loose implant magnet, causing pain around the implanted area when using the baha sound processor.Excessive skin thickening and skin growing over the abutment are common complications with baha abutments.Issues can be resolved with clinical case management.An abutment change or removal is a minor procedure involving the exchange of external hardware by unscrewing the abutment from the implant and screwing a new one onto the implant, with no surgical involvement.The baha surgery guide include instructions how to adjust and tighten the abutment.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 10MM
• Common Device Name: COCHLEAR BAHA CONNECT 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, 435 3 3; SW 435 33
• Manufacturer Contact: asyikin zulkhairi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24613863
• Report Number: 6000034-2026-00955
• Device Sequence Number: 10137752
• Product Code: MAH
• UDI-Device Identifier: 09321502022712
• UDI-Public: (01)09321502022712(10)1667133(17)280907
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2026

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 Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH1667133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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