MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92130
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on december 15, 2017, (b)(4).
Event or Problem Description
Per the clinic, the patient experienced an infection and skin overgrowth at the abutment site.Additional information was requested; however, not made available as of the date of this report.
Additional Manufacturer Narrative
Correction: the previous or initial mdr submitted on december 15, 2017, was filed inadvertently.There was no infection or serious injury has occurred.
Additional Manufacturer Narrative
Additional information was received: it was reported that the patient experienced skin overgrowth at the abutment site.Subsequently, revision surgery under a general anaesthetic was performed (date not reported) to remove osteomas around the abutment site and the abutment was replaced with a longer abutment.The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Excessive skin thickening and skin growing over the abutment are relatively common soft tissue complications.The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan and the status is updated on a monthly basis.This event is added to this monitoring.

• Brand Name: BA300 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: 7119479
• Report Number: 6000034-2017-02275
• Device Sequence Number: 1470045
• Product Code: MAH
• UDI-Device Identifier: 09321502019552
• UDI-Public: (01)09321502019552
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2018

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 Model Number: 92130
• Device Catalogue Number: 92130
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/14/2017; 01/11/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/09/2018; 02/05/2018
• 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