MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 8MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93334
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on october 25, 2023.
Event or Problem Description
Per the clinic, the patient was placed under general anesthesia on (b)(6) 2023, in order to replace the abutment.
Additional Manufacturer Narrative
Correction: the correct date of awareness is october 02, 2023 not october 03, 2023 as previous reported.This report is submitted on october 31, 2023.

• Brand Name: BA400 ABUTMENT 8MM
• 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: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18000509
• Report Number: 6000034-2023-03435
• Device Sequence Number: 12686807
• Product Code: MAH
• UDI-Device Identifier: 09321502022743
• UDI-Public: (01)09321502022743(10)167166(17)210902
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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): 10/02/2023

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: 09/02/2021
• Device Model Number: 93334
• Device Catalogue Number: 93334
• Device Lot Number: 167166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 10/31/2023
• 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: 52 YR
• Patient Sex: Male