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 Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812)
Date of Event	05/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on may 17, 2018, (b)(4).
Event or Problem Description
Per the clinic, the patient developed cellulitis at the implant site and was treated with antibiotics (type not reported) on (b)(6) 2015.On (b)(6) 2015, the patient experienced skin overgrowth at the implant site.Subsequently, a biopsy punch was performed in order to expose the implant.On (b)(6) 2016, the patient experienced an infection at the implant site, and was treated with oral antibiotics; however, the issue reoccurred, and the patient presented once more to clinic on (b)(6) 2016, with infection.The patient was treated with another course of oral antibiotics.

• 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; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 7521086
• Report Number: 6000034-2018-01138
• Device Sequence Number: 19192065
• Product Code: LXB
• UDI-Device Identifier: 09321502019514
• UDI-Public: (01)09321502019514(10)91160(17)160630
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: 06/30/2016
• Device Model Number: 92126
• Device Catalogue Number: 92126
• Device Lot Number: 91160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/16/2018
• 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
• Patient Age: 40 YR