MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93357
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on july 01, 2024.
Event or Problem Description
Per the clinic, the abutment was removed under general anesthesia on (b)(6) 2024, due to a skin overgrowth.During the procedure, the patient underwent revision surgery to remove the excess skin.

• Brand Name: BA300 ABUTMENT 12MM
• 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: ashwinii chelvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19641155
• Report Number: 6000034-2024-02308
• Device Sequence Number: 8673570
• Product Code: LXB
• UDI-Device Identifier: 09321502033435
• UDI-Public: (01)09321502033435(10)COH1349015(17)241203
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 06/04/2024

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: 12/03/2024
• Device Model Number: 93357
• Device Catalogue Number: 93357
• Device Lot Number: COH1349015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/30/2024
• 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 Age: 17 YR
• Patient Sex: Male