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 Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on september 05, 2018, (b)(4).
Event or Problem Description
Per the audiologist, it was reported that the patient experienced recurrent infections at the abutment site.Subsequently, the patient underwent revision surgery (date not reported) in order to have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.
Additional Manufacturer Narrative
Correction: the patient was not converted to a subcutaneous baha implant system as previously reported.It was reported that the internal fixture could not be used to site a magnet due to a broken abutment and therefore the patient was reimplanted on the contralateral side.This report is submitted on september 25, 2018.

• 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: 7845002
• Report Number: 6000034-2018-01758
• Device Sequence Number: 19225972
• Product Code: LXB
• UDI-Device Identifier: 09321502019514
• UDI-Public: (01)09321502019514(10)91160(17)160630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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