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

Model Number	92129
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on december 12, 2023.
Event or Problem Description
Per the clinic, the device was explanted under general anesthesia on (b)(6) 2023, due to wanting to improve sound outcomes.The patient was re-implanted with a transcutaneous osia implant system during the same surgery.

• Brand Name: BI300 IMPLANT 4 MM
• 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: 18307954
• Report Number: 6000034-2023-03979
• Device Sequence Number: 6832521
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)COH1254095(17)230903
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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: 09/03/2023
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: COH1254095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/11/2023
• 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 Age: 41 YR
• Patient Sex: Male