MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 9 september 2020.

Event Description

Per the clinic, the patient experienced infections and skin overgrowth at abutment site; subsequently the patient was placed under general anaesthesia to undergo skin revision surgery and covert the patient to a transcutaneous osia baha implant system.

Manufacturer Narrative

This report is submitted on 28 september 2020.

Event Description

Correction: it was reported that only the abutment was removed, the device remains in-situ.The patient was treated with topical antibiotics.

• Brand Name: BI300 IMPLANT 4 MM
• 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: 10505557
• MDR Text Key: 206095417
• Report Number: 6000034-2020-02487
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 093215020195459
• UDI-Public: (01)093215020195459(10)89651(17)160531
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/28/2020,09/02/2020

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 Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: 89651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2020
• Distributor Facility Aware Date: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention