MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93333
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	01/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on february 07, 2022.
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth on the abutment.Subsequently, the patient was placed under general anesthesia and underwent revision surgery to remove the excess skin on (b)(6) 2022.

• Brand Name: BA400 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: kohilah nadaraja ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13468260
• Report Number: 6000034-2022-00410
• Device Sequence Number: 14625454
• Product Code: MAH
• UDI-Device Identifier: 09321502022736
• UDI-Public: (01)09321502022736(10)140175(17)180228
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2022

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: 02/28/2018
• Device Model Number: 93333
• Device Catalogue Number: 93333
• Device Lot Number: 140175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2022
• Initial Report FDA Received Date: 02/07/2022
• 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 Age: 14 YR
• Patient Sex: Male