MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90434

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6) 2018.(b)(4).

Event Description

It was reported that the patient experienced an infection and skin breakdown at the abutment site.Subsequently, the device was explanted (date not reported).

Manufacturer Narrative

Correction: the product details reported on the initial report are not correct.The details of the implant fixture are currently unknown.Should the device details become available, a supplementary report shall be submitted.

Manufacturer Narrative

No specific device analysis is deemed necessary at this moment.No deviations that explain the reported issue is found.There are no indications that the reported issue is related to any device failure.Previously product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.No ocular inspection of the returned product is therefore deemed necessary.) adverse skin reactions around the baha abutment, ranging from slight redness to infected tissue, as well as excessive skin thickening and skin growing over the abutment are common complications with baha implants.The report frequency for these complications is being monitored under cbas complaint and mdr data monitoring plan and the status is updated on a monthly basis.This event is added to this monitoring.There are no indications that a product failure has contributed to the reported issue (b)(4).

• Brand Name: FLANGE FIXTURE ST 4MM 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: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7344047
• MDR Text Key: 102569557
• Report Number: 6000034-2018-00604
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

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 Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: 113559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/05/2018; 03/28/2018
• Supplement Dates FDA Received: 03/21/2018; 04/05/2018
• 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