MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92134

Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)

Patient Problem Bacterial Infection (1735)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is filed on october 12, 2016.Implanted device remains.

Event Description

Per the clinic, the patient developed infection at abutment site, however the issue could not be resolved; subsequently the patient was treated with oral and topical antibiotics (date and duration not reported).The implanted device remains.

Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2016, in order to place an internal magnet.The implanted device remains.(b)(4).

• Brand Name: BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 435 33, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial, co 80111
• Manufacturer Contact: pavana nayak ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6019626
• MDR Text Key: 57044157
• Report Number: 6000034-2016-02005
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

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: 92134
• Device Catalogue Number: 92134
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/18/2016
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• 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
• Patient Age: 14 YR