MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XEMFLIFI DBM PLUS, 3CC; XEMPLIFI DBM

Model Number 8103.0203S

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 03/13/2015

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned for evaluation.A thorough investigation was completed, and no deviations to processing were identified.There have been no previous reported issues of this type.Xemplifi plus is a sterile packaged product.Sterility can be assured as long as the product package is not compromised.In this case, there was no reported issues with the sterility of the product.Postoperative infection can be caused from a wide variety of sources.In this event, it is not possible to determine the exact cause of the infection.This report is associated with mdr (b)(4).

Event Description

It was reported to globus that a patient had a fusion surgery c5-6 on (b)(6) 2016 at (b)(6) hospital (b)(6).The patient later developed an abscess/infection, and had to have the spinal hardware, coalition spacer, and xemplifi putty removed.The removal surgery took place (b)(6) 2015.The removal surgery was performed at (b)(6) hospital (b)(6).The removal surgery was performed by different surgeon than the initial surgery.

• Brand Name: XEMFLIFI DBM PLUS, 3CC
• Type of Device: XEMPLIFI DBM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave.; audubon PA 19403
• Manufacturer Contact: daniel paul, vp, qa & it ; 2560 general armistead ave.; audubon, PA 19403 ; 6109301800
• MDR Report Key: 4990515
• MDR Text Key: 22538638
• Report Number: 3004142400-2015-00032
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Not Applicable
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8103.0203S
• Device Lot Number: 1362376553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• 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: 50 YR