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

Model Number	93101
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on january 24, 2018.(b)(4).
Event or Problem Description
It was reported that the patient experienced a loss of osseointegration subsequent to the patient experiencing pain and secretion at the abutment site.The device was explanted and the patient was treated with antibiotics.

• Brand Name: COCHLEAR¿ VISTAFIX® VXI300 IMPLANT 4MM
• Common Device Name: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 7214567
• Report Number: 6000034-2018-00251
• Device Sequence Number: 16184199
• Product Code: FZE
• UDI-Device Identifier: 09321502021722
• UDI-Public: (01)09321502021722(10)158224
• Combination Product (Y/N): N
• PMA/510(K) Number: K945154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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 Model Number: 93101
• Device Catalogue Number: 93101
• Device Lot Number: 158224
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/24/2018
• 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