MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92132
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth at the abutment site and subsequently, underwent a skin revision surgery under general anesthesia on (b)(6) 2021 in order to remove the excess skin.

• Brand Name: BA210 ABUTMENT 5.5MM 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: 12007032
• Report Number: 6000034-2021-01765
• Device Sequence Number: 11921556
• Product Code: LXB
• UDI-Device Identifier: 09321502018951
• UDI-Public: (01)09321502018951(10)COH870977(17)210421
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2021
• Report Date (Section F): 06/16/2021

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: 04/21/2021
• Device Model Number: 92132
• Device Catalogue Number: 92132
• Device Lot Number: COH870977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2021
• 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: 17 YR
• Date Report Sent to FDA: 06/16/2021