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

Model Number 92129

Device Problem Insufficient Information (3190)

Patient Problems No Information (3190); Missing Value Reason (3192)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, a baha bi300 implant 4mm (92129) was explanted on (b)(6) 2019.The clinic did not provide additional information.

• 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: 8978029
• MDR Text Key: 157040234
• Report Number: 6000034-2019-01692
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502022729
• UDI-Public: (01)09321502022729(10)136036(17)180531
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2019,08/21/2019

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 Expiration Date: 05/31/2018
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: 136036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2019
• Distributor Facility Aware Date: 08/21/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• 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: 69 YR