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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, it was reported that the patient experienced recurrent skin overgrowth issues at the implant site.Subsequently, the patient underwent revision surgery on (b)(6) 2019, in order to convert the patient to a transcutaneous baha implant system.During the procedure, the abutment was removed and a magnet placed on the internal fixture.

• 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: 9470960
• Report Number: 6000034-2019-02770
• Device Sequence Number: 3244021
• Product Code: LXB
• UDI-Device Identifier: 09321502018968
• UDI-Public: (01)09321502018968(10)COH401900(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Importer
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/20/2019
• Report Date (Section F): 12/15/2019

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: 10/31/2018
• Device Model Number: 92133
• Device Catalogue Number: 92133
• Device Lot Number: COH401900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2019
• 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: 14 YR
• Date Report Sent to FDA: 12/15/2019