MAUDE Adverse Event Report: MEDTRONIC XOMED INC. AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE; DEVICE, ANTI-SNORING

Model Number XOM UNK REPOSE

Device Problem Extrusion (2934)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4) issue associated with the unintended projection of device component materials.The device remains in the patient.Therefore, no product analysis has been performed.This device is used for therapeutic purposes.

Event Description

The physician performed a tongue suspension on a patient 6-7 years ago.It was reported that the patient has come in for a couple episodes of some collections (infections) at the floor of his mouth where the screw was put in.The collections were drained and cleared up with antibiotics.However, when the physician did a flex scope on the patient he could see a loop of suture visible at the base of the tongue.The suture worked its way through the tissue and is now exposed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 5311307
• MDR Text Key: 33895874
• Report Number: 1045254-2015-00431
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XOM UNK REPOSE
• Device Catalogue Number: XOM UNK REPOSE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention