MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XPAND CORPECTOMY SPACE,R SMALL, 12X14, 3.5/3; XPAND CORPECTORMY SPACER, SMALL.

Model Number 1116.126

Device Problem Collapse (1099)

Patient Problem No Information (3190)

Event Date 05/08/2014

Event Type  malfunction  

Event Description

It was reported globus that a patient was experiencing a slight collapse of an implanted xpand cage.Initial surgery took place (b)(6) 2014.No revision surgery has been scheduled as yet.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned for evaluation, and a thorough investigation could not be completed as no lot number was provided.If and when revision surgery occurs, a supplemental report will be filed.

• Brand Name: XPAND CORPECTOMY SPACE,R SMALL, 12X14, 3.5/3
• Type of Device: XPAND CORPECTORMY SPACER, SMALL.
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave.; audubon PA 19403
• Manufacturer Contact: daniel paul, vp ; 2560 general armistead ave.; audubon, PA 19403 ; 6109301800
• MDR Report Key: 4088249
• MDR Text Key: 4713292
• Report Number: 3004142400-2014-00026
• Device Sequence Number: 1
• Product Code: MQP
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1116.126
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2014
• Initial Date FDA Received: 06/04/2014
• 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): Other
• Patient Age: 53 YR