MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 4MM W ABUTMENT 5.5MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92134

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment.Subsequently, the patient underwent skin revision under general anesthesia to remove the excess skin on (b)(6), 2014.

Manufacturer Narrative

This report is submitted on (b)(6), 2023.

• Brand Name: BIA210 FLANGE FIXTURE ST 4MM W ABUTMENT 5.5MM
• Type of Device: 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: mastura ruhanet ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18045132
• MDR Text Key: 327017829
• Report Number: 6000034-2023-03554
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502018982
• UDI-Public: (01)09321502018982(10)COH141633(17)141102
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/02/2014
• Device Model Number: 92134
• Device Catalogue Number: 92134
• Device Lot Number: COH141633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male