MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 HEALING ABUTMENT; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number	92998
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on november 10, 2021.
Event or Problem Description
Per the clinic, the patient experienced an infection and skin irritation on the abutment site (specific date not reported) and subsequently, was placed under general anesthesia on (b)(6) 2021, in order to remove the abutment.It was reported that the patient was treated with oral and topical antibiotics (specific date and duration not reported).

• Brand Name: COCHLEAR¿ VISTAFIX® VXA300 HEALING ABUTMENT
• Common Device Name: COCHLEAR BAHA VISTAFIX SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12785113
• Report Number: 6000034-2021-03415
• Device Sequence Number: 20104167
• Product Code: FZE
• UDI-Device Identifier: 09321502021708
• UDI-Public: (01)09321502021708(10)184598(17)240916
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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 Expiration Date: 09/16/2024
• Device Model Number: 92998
• Device Catalogue Number: 92998
• Device Lot Number: 184598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male