MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 18, 2019, by cochlear ltd.

Event Description

Per the clinic on (b)(6) 2019, the patient experienced a loss of osseointegration resulting in dislodged his baha implant.The clinic requested an new implant for a planned surgery on (b)(6) 2019.

• Brand Name: BI300 IMPLANT 4 MM
• 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: 9079965
• MDR Text Key: 159939178
• Report Number: 6000034-2019-01952
• 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: 09/18/2019,08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Distributor Facility Aware Date: 08/28/2019
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention