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

Model Number ASKU

Device Problem Loss of Osseointegration (2408)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is filed on october 03, 2019.

Event Description

Per the clinic, the patient experienced a loss of osseointegration, resulting in fixture loss.Re-implantation is planned but has not taken place as of the date of this report.

Event Description

Correction: the previous or initial mdr submitted on (b)(6) 2019 was filed inadvertently.The reported device is not manufactured by cochlear, therefore no serious injury has occurred.

Manufacturer Narrative

This report is submitted on 11 november 2019.

• Brand Name: NI
• 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: 9149337
• MDR Text Key: 161072626
• Report Number: 6000034-2019-02040
• Device Sequence Number: 1
• Product Code: LXB
• 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: 11/11/2019,10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2019
• Distributor Facility Aware Date: 10/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention