MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTACT SYSTEM; LXB

Model Number BIM400

Device Problem Extrusion (2934)

Patient Problems Hematoma (1884); Patient Problem/Medical Problem (2688)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

The patient date of birth and date of initial implantation was not reported.(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient developed a hematoma at the implant site.Subsequently, the hematoma was drained by the patient's physician (date not reported).Following the procedure, the skinflap broke down, resulting in exposure of the internal magnet.Revision surgery is planned; however, it is unknown whether this has yet to occur as of the date of this report.

Manufacturer Narrative

(b)(4).Per the clinic, it was reported that the patient was treated with oral and topical antibiotics (date and duration not reported).This report is filed (b)(6) 2016.Implanted device remains.

Manufacturer Narrative

Correction: the brand product name is cochlear baha attact system, not flange fixture and abutment, as previously reported.Correction: the common device name and product code is lxb, not mah as previously reported.Correction: the correct model # is bim400, not ba400 as previously reported.Correction: the correct catalog # is 93550, not 93333 as previously reported.Correction: the correct 510(k)# is k131240, not k121317 as previously reported.(b)(4).

Manufacturer Narrative

(b)(4).Per the clinic, the patient underwent revision surgery on (b)(6) 2016, to remove the internal magnet and replace with an abutment.(b)(6).

Manufacturer Narrative

Correction: the correct patient identifier is (b)(6) , not (b)(6) as previously reported.It was reported that the patient underwent revision surgery on (b)(6) 2016, to remove the internal magnet and abutment was placed on the fixture.

• Brand Name: COCHLEAR BAHA ATTACT SYSTEM
• Type of Device: LXB
• 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 parkview avenue; centennial, co 80111; centennial CO 80111
• Manufacturer Contact: pavana nayak ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5867404
• MDR Text Key: 51812950
• Report Number: 6000034-2016-01521
• Device Sequence Number: 1
• Product Code: LXB
• 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
• Source Type: company representative,health
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2016

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: BIM400
• Device Catalogue Number: 93550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/16/2016
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/06/2016; 09/15/2016; 10/06/2016; 10/18/2016
• 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: 65 YR