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

Model Number 95772

Device Problem Extrusion (2934)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7246792
• MDR Text Key: 99183422
• Report Number: 6000034-2018-00301
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502028707
• UDI-Public: (01)09321502028707(10)124910(17)190302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2019
• Device Model Number: 95772
• Device Catalogue Number: 95772
• Device Lot Number: 124910
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention