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

Model Number	92126
Medical Device Problem Codes	Loss of Osseointegration (2408); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
This report is submitted on september 09,2022.
Additional 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
• Common Device Name: 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
• Report Number: 6000034-2022-02624
• Device Sequence Number: 5797173
• Product Code: LXB
• UDI-Device Identifier: 09321502019514
• UDI-Public: (01)09321502019514(10)90532(17)160531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown