MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Host-Tissue Reaction (1297)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth on the abutment.The patient was placed under a general anaesthetic on (b)(6) 2020, in order to remove the excess skin and replace the abutment.The implanted device remains.

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 6MM
• 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: 10486276
• Report Number: 6000034-2020-02300
• Device Sequence Number: 2452310
• Product Code: LXB
• UDI-Device Identifier: 09321502019521
• UDI-Public: (01)09321502019521(10)123370(17)170531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2020
• Report Date (Section F): 09/03/2020

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: 05/31/2017
• Device Model Number: 92127
• Device Catalogue Number: 92127
• Device Lot Number: 123370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2020
• 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
• Patient Age: 12 YR
• Date Report Sent to FDA: 09/03/2020