MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM

Model Number	90434
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Infection (4544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on july 17, 2023.
Event or Problem Description
Per the clinic, the patient developed an infection around the implant site.Additional information has been requested but it has not been made available as of the date of this report.
Additional Manufacturer Narrative
Per the clinic, the patient was treated with topical antibiotics (specific date and duration not reported) and underwent skin revisions (date not reported) in order to remove the granulation tissue around the abutment.The infection resolved.This report is submitted on august 18, 2023.
Additional Manufacturer Narrative
Per the clinic, the patient was treated with oral and topical antibiotics on (b)(6) 2023 (duration not reported).This report is submitted on september 15, 2023.

• Brand Name: FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
• Common Device Name: COCHLEAR BAHA CONNECT 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: nurshahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17331201
• Report Number: 6000034-2023-02469
• Device Sequence Number: 15357082
• Product Code: LXB
• UDI-Device Identifier: 09321502014359
• UDI-Public: (01)09321502014359(10)COH185718(17)160101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2023

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: 01/01/2016
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: COH185718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/10/2023; 09/06/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/17/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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