MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 2; COCHLEAR BAHA ATTRACT SYSTEM

Model Number	95772
Medical Device Problem Code	Extrusion (2934)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Per the surgeon, the patient experienced extrusion of the magnet and subsequently was treated with an oral antibiotic (date and duration not reported).On (b)(6) 2018 the patient underwent a skin revision under a general anaesthetic.There are plans to resume use of the device once the site has healed.

• Brand Name: SP MAGNET 2
• Common Device Name: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 7246792
• Report Number: 6000034-2018-00301
• Device Sequence Number: 801362
• Product Code: LXB
• UDI-Device Identifier: 09321502028707
• UDI-Public: (01)09321502028707(10)124910(17)190302
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2018

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: 03/02/2019
• Device Model Number: 95772
• Device Catalogue Number: 95772
• Device Lot Number: 124910
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/07/2018
• 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