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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Discharge (2225)

Event Date 02/02/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned to the manufacturer.

Event Description

Per the clinic, the patient developed an infection at the implant site, resulting in pain and discharge.Oral antibiotic treatment was administered (type and duration not reported), however; the issue could not be resolved.Subsequently, the device was explanted on (b)(6) 2015.

• 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 2 2; SW 435 22
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 5043779
• MDR Text Key: 24645955
• Report Number: 6000034-2015-01731
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 08/10/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 33 YR