MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR VISTAFIX VXI300 IMPLANT 4MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93101
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on november 23, 2020.
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth on the abutment.The patient underwent a revision surgery on (b)(6) 2020, in order to remove overgrown tissue.The implanted device remains.
Additional Manufacturer Narrative
It is now reported that the procedure was performed under a general anaesthetic.This report is submitted on december 14, 2020.

• Brand Name: COCHLEAR VISTAFIX VXI300 IMPLANT 4MM
• 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: 10881835
• Report Number: 6000034-2020-03271
• Device Sequence Number: 16957396
• Product Code: FZE
• UDI-Device Identifier: 09321502021722
• UDI-Public: (01)09321502021722(10)COH1311018(17)240522
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K945154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 05/22/2024
• Device Model Number: 93101
• Device Catalogue Number: 93101
• Device Lot Number: COH1311018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 12/13/2020
• 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