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

Model Number 90480

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6) 2017, by (b)(4).

Event Description

Per the clinic, the patient experienced skin overgrowth at the abutment site.Subsequently, the patient underwent revision surgery in order to excise the excess skin (date not reported).Following the procedure, the patient experienced wound healing issues.The surgeon made the decision to remove the abutment and close the wound.The fixture remains insitu.

• Brand Name: FLANGE FIXTURE ST 3MM W. BAHA ABUTMENT
• Type of Device: COCHLEAR BAHA CONNECT 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: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6749660
• MDR Text Key: 81227799
• Report Number: 6000034-2017-01471
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 0932150201429890480
• UDI-Public: (01)0932150201429890480
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K984162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/17/2017

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 Model Number: 90480
• Device Catalogue Number: 90480
• Device Lot Number: 015CMC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention