MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92133
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Hearing Impairment (1881)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on october 11, 2017, (b)(4).
Event or Problem Description
Per the clinic, the patient experienced a recurrent wound with blistering, swelling and ulceration at the implant site for a duration of 3 years.The first occurrence began in 2014, and the patient reportedly underwent revision surgery in (b)(6) 2014, in order to excise excess skin at the abutment and clean the wound.Due to the ongoing healing issues, the patient was placed under general anaesthesia on (b)(6) 2017, in order to excise additional skin overgrowth at the abutment site.The abutment was removed; however, the implanted fixture remains insitu.

• Brand Name: BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 6939402
• Report Number: 6000034-2017-01779
• Device Sequence Number: 13594777
• Product Code: LXB
• UDI-Device Identifier: 09321502018968
• UDI-Public: (01)09321502018968
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: 92133
• Device Catalogue Number: 92133
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention