MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA310 IMPLANT 4MM W ABUTMENT 14MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	P1340893
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient initially experienced soft tissue problems causing persistent localized inflammation around the abutment site.Subsequently, the abutment was removed on (b)(6) 2024, to allow the skin to heal.However, on (b)(6) 2024, the patient was placed under general anaesthesia in order to explant the internal fixture due to an infection at the implant site.The patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: BIA310 IMPLANT 4MM W ABUTMENT 14MM
• 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: 20731166
• Report Number: 6000034-2024-03939
• Device Sequence Number: 21056261
• Product Code: MAH
• UDI-Device Identifier: 09321502043908
• UDI-Public: (01)09321502043908(10)COH1275588(17)240116
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 11/20/2024

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: 01/16/2024
• Device Model Number: P1340893
• Device Catalogue Number: P1340893
• Device Lot Number: COH1275588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/20/2024
• 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: Male