MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB

Model Number BIA210

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The date of initial implantation is unknown.(b)(4).Implanted device remains.

Event Description

It was reported that the patient developed an infection at the abutment site.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Correction: the correct catalog # is 92134; and not 32134 as previously reported.Implanted device remains.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• 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: 5927904
• MDR Text Key: 53895295
• Report Number: 6000034-2016-01735
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

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: BIA210
• Device Catalogue Number: 92134
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/11/2016
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/05/2016; 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