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

Model Number 90434

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 11, 2018, (b)(4).

Event Description

Per the surgeon, the patient experienced skin overgrowth at the abutment site.Subsequently, the patient underwent revision on (b)(6) 2018 in order to excise the excess skin, debride the granulation tissue and the patient was administered injectable steroids.

Manufacturer Narrative

Per the clinic, it was reported that the patient underwent replacement of the abutment and skin revision under a general anaesthetic on (b)(6) 2018.

• Brand Name: FLANGE FIXTURE ST 4MM 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 (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43533 ; SW 43533
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7676521
• MDR Text Key: 113619336
• Report Number: 6000034-2018-01392
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 17 YR