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 Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on december 30, 2020.
Event or Problem Description
Per the surgeon, the patient experienced a loss of osseointegration on (b)(6) 2020, resulting in fixture loss.The patient was treated with antibiotics (type and duration not reported).Reimplantation is planned but has not taken place at the time of this report.

• 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: 11092684
• Report Number: 6000034-2020-03610
• Device Sequence Number: 13664516
• Product Code: FZE
• UDI-Device Identifier: 09321502021722
• UDI-Public: (01)09321502021722(10)COH1378760(17)250324
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K945154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 03/24/2025
• Device Model Number: 93101
• Device Catalogue Number: 93101
• Device Lot Number: COH1378760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/29/2020
• 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: 6 YR