MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92132

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Impaired Healing (2378)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 2, 2023.

Event Description

Per the clinic, the patient experienced a recurrent skin overgrowth on the abutment.Subsequently, the device was explanted on (b)(6) 2023, and the patient was re-implanted with another cochlear device during the same surgery.

Manufacturer Narrative

Correction: the initial mdr submitted on november 02, 2023 was filed inadvertently.No explantation has occurred.Per the clinic, the patient was placed under general anesthesia on (b)(6) 2023 in order to remove the abutment.The internal fixture remains.This report is submitted on december 28, 2023.

• Brand Name: BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
• 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: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18052666
• MDR Text Key: 327125726
• Report Number: 6000034-2023-03747
• Device Sequence Number: 1
• Product Code: LXB
• 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,Followup
• Report Date: 12/05/2023

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: 92132
• Device Catalogue Number: 92132
• Device Lot Number: COH141633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/27/2023
• 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 Age: 68 YR
• Patient Sex: Male