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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Host-Tissue Reaction (1297)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on september 28, 2018, (b)(4).
Event or Problem Description
Per the clinic, it was reported that the patient experienced skin overgrowth at abutment sites and subsequently underwent skin revision on (b)(6) 2018.

• 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: 7917352
• Report Number: 6000034-2018-01966
• Device Sequence Number: 13902644
• Product Code: LXB
• UDI-Device Identifier: 09321502021722
• UDI-Public: (01)09321502021722(10)COH1120335(17)220427
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K945154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: 04/27/2022
• Device Model Number: 93101
• Device Catalogue Number: 93101
• Device Lot Number: COH1120335
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/28/2018
• 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