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

Model Number 90434

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 8, 2020.

Event Description

Per the surgeon, the patient experienced skin granulation around the abutment and pain which was treated with a skin revision and the administration of antibiotics (type of administration unknown).The abutment was replaced with a longer abutment on (b)(6) 2020.

• Brand Name: FLANGE FIXTURE ST 4 MM W BAHA ABUTMENT
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 10500438
• MDR Text Key: 205882914
• Report Number: 6000034-2020-02395
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502014359
• UDI-Public: (01)09321502014359(10)COH201124(17)07312016
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: COH201124
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• 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: 76 YR