MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92346
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on april 14, 2023.
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration of the implant on (b)(6) 2022.The patient was re-implanted with a new device.

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 9MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsv[?]gen 14; m[?]lnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 16740101
• Report Number: 6000034-2023-01194
• Device Sequence Number: 15164286
• Product Code: LXB
• UDI-Device Identifier: 09321502019767
• UDI-Public: (01)09321502019767(10)COH1413465(11)11172020(17)11222025
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/22/2025
• Device Model Number: 92346
• Device Catalogue Number: 92346
• Device Lot Number: COH1413465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male