MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU COCHLEAR BAHA CONNECT SYSTEM

Model Number ASKU

Device Problem Loss of Osseointegration (2408)

Patient Problem Head Injury (1879)

Event Type  Injury  

Event Description

Per the clinic, the patient sustained a head trauma at the implant site. It was reported a week following this incident, the patient experienced a loss of osseointegration resulting in fixture loss. There are no plans to reimplant the patient with a new device as of the date of this report.

• Brand Name: ASKU
• 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: 10486313
• MDR Text Key: 205453467
• Report Number: 6000034-2020-02484
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/03/2020,08/13/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/02/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: ASKU
• Device Catalogue Number: ASKU
• Device LOT Number: ASKU
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2020
• Distributor Facility Aware Date: 08/13/2020
• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 09/02/2020 Patient Sequence Number: 1