MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92129
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
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.
Event or Problem Description
Per the clinic, the patient experienced chronic pain from the implant (specific date not reported).Subsequently, the patient was placed under general anesthesia on (b)(6) 2025, where implant was explanted.The abutment was also removed during the same surgery and the site was sutured off.

• Brand Name: BI300 IMPLANT 4 MM
• 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: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 22173139
• Report Number: 6000034-2025-02084
• Device Sequence Number: 7957683
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)COH1233460(17)230516
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 05/16/2023
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/09/2025
• 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