MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93357
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on october 8.2020.
Event or Problem Description
Per the surgeon, the patient experienced skin overgrowth that was treated with oral and topical antibiotics.The implant remains in-situ.
Additional Manufacturer Narrative
It has now been reported that the abutment was removed under a general anaesthetic.This report is submitted on november 13, 2020.
Event or Problem Description
It has now been reported that the abutment was removed under a general anaesthetic.

• Brand Name: BA300 ABUTMENT 12MM
• 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: 10646563
• Report Number: 6000034-2020-02719
• Device Sequence Number: 2617781
• Product Code: LXB
• UDI-Device Identifier: 09321502033435
• UDI-Public: (01)09321502033435(10)COH1061866(17)11232021
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020
• Report Date (Section F): 11/13/2020

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: 11/23/2021
• Device Model Number: 93357
• Device Catalogue Number: 93357
• Device Lot Number: COH1061866
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/21/2020
• Date Report to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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: 15 YR
• Date Report Sent to FDA: 11/13/2020