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

Device Problem Loss of Osseointegration (2408)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of osseointegration, resulting in both the abutment and implant came out.It was reported that the site had some swelling which was treated with antibiotics.A revision surgery to replace the abutment has been planned but not yet performed as of the date of this report.

• 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: 10618403
• MDR Text Key: 209554154
• Report Number: 6000034-2020-02709
• 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: Physician
• Type of Report: Initial
• Report Date: 10/02/2020,09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2020
• Distributor Facility Aware Date: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention