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

Model Number	93101
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on 07 april 2021.
Event or Problem Description
Per the clinic, the patient experienced a loss of ossseointegration resulting in implant loss.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report, (b)(6) 2021.
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration resulting in implant loss.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report, (b)(6) 2021.
Additional Manufacturer Narrative
Corrections have been made to b5 (description of event - date of this report), d4 (catalog no and lot no updated), d9 (device available for evaluation), g1 (manufacturing site), h3 (device evaluated by manufacturer), h6 (clinical code & impact code).This report is submitted on (b)(6) 2021.

• Brand Name: COCHLEAR VISTAFIX VXI300 IMPLANT 4MM
• Common Device Name: COCHLEAR BAHA VISTAFIX SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 11625858
• Report Number: 6000034-2021-01042
• Device Sequence Number: 3919506
• Product Code: FZE
• UDI-Device Identifier: 09321502021722
• UDI-Public: (01)09321502021722(10)159688(17)190630
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K945154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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 Model Number: 93101
• Device Catalogue Number: 93101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 07/06/2021
• 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