MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92133

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 17, 2020.

Event Description

Per the clinic, it was reported that the patient developed an infection and skin overgrowth at the abutment site.Subsequently, the patient was treated with topical antibiotics.Revision surgery is planned; however, yet to occur as of the date of this report.

Manufacturer Narrative

The patient underwent successful conversion from the baha connect to the osia under a general anaesthetic on (b)(6) 2020.This report is submitted on august 21, 2020.

• Brand Name: BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE
• 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
• MDR Report Key: 10286790
• MDR Text Key: 199234944
• Report Number: 6000034-2020-01826
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2020,07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92133
• Device Catalogue Number: 92133
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2020
• Date Report to Manufacturer: 07/31/2020
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention