MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FIXTURE ST 3MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number	90438
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on august 7, 2020.
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.Reimplantation is planned but has not taken place as of the date of this report.

• Brand Name: FIXTURE ST 3MM
• 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: 10377182
• Report Number: 6000034-2020-02062
• Device Sequence Number: 14334785
• Product Code: FZE
• UDI-Device Identifier: 09321502014335
• UDI-Public: (01)09321502014335(10)COH264706(17)171031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K945154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: 10/31/2017
• Device Model Number: 90438
• Device Catalogue Number: 90438
• Device Lot Number: COH264706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/06/2020
• 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