MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 3MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM

Model Number	90480
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Host-Tissue Reaction (1297)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on june 3, 2019.(b)(4).
Event or Problem Description
Per the surgeon, the patient experienced a skin overgrowth at the abutment site and subsequently underwent a skin revision (date not reported) to replace the abutment and cauterize the skin.It was also reported that the patient was administered topical antibiotics (date not reported).

• Brand Name: FLANGE FIXTURE ST 3MM W. BAHA ABUTMENT
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 8661446
• Report Number: 6000034-2019-00880
• Device Sequence Number: 16665732
• Product Code: LXB
• UDI-Device Identifier: 09321502014298
• UDI-Public: (01)09321502014298(10)609129(17)121130
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K984162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 11/30/2012
• Device Model Number: 90480
• Device Catalogue Number: 90480
• Device Lot Number: 609129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention