MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92132

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Host-Tissue Reaction (1297)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the recipient experienced a bone overgrowth on the abutment.With the recipient under a general anaesthetic, an abutment change revision surgery was performed on (b)(6) 2019.The issue has been resolved with medical/surgical intervention.

• Brand Name: BA210 ABUTMENT 5.5MM 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: 8783621
• MDR Text Key: 150805653
• Report Number: 6000034-2019-01193
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/12/2019,06/27/2019

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: 92132
• Device Catalogue Number: 92132
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Distributor Facility Aware Date: 06/27/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR