MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92126

Device Problems Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)

Patient Problems Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Type  Injury  

Event Description

Per the clinic, the patient underwent revision surgery (date not reported).Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on september 09,2022.

Manufacturer Narrative

Correction: the initial mdr submitted on september 9, 2022, was filed inadvertently.No revision surgery has occurred.The correct d1 and d4 has been updated to bia300 implant 3mm w abutment 6mm and 92126 respectively.Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.The patient was reimplanted with another cochlear device on (b)(6) 2022.This report is submitted on november 22, 2022.

• Brand Name: BIA300 IMPLANT 3MM W ABUTMENT 6MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: aini yusof ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15388500
• MDR Text Key: 299552660
• Report Number: 6000034-2022-02624
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019514
• UDI-Public: (01)09321502019514(10)90532(17)160531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 92126
• Device Catalogue Number: 92126
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention