MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92131

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 11, 2019.

Event Description

Per the clinic, the patient was placed under general anaesthetic in order to replace the patient's abutment due to skin overgrowth at the implant site.No patient injury was reported during this event.

Manufacturer Narrative

Correction: correct product details have now been updated.This report is submitted on 11 november 2019.

• Brand Name: BA300 ABUTMENT 9MM
• 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: 8985274
• MDR Text Key: 159432158
• Report Number: 6000034-2019-01846
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: 92131
• Device Catalogue Number: 92131
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• 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
• Patient Age: 14 YR