MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SECURE-C CORE, 13X14, 7MM

Model Number 414.207S

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 02/13/2015

Event Type  Injury  

Event Description

It was reported to globus that a patient complained of bilateral radicular symptoms in the upper extremities.During physical therapy, patient received manual traction which alleviated the symptoms.The surgeon believed that if he could remove the existing 7mm core and replace it with a larger size core, it would provide the distraction necessary to alleviate the issue all together.The initial surgery was on (b)(6) 2013, the revision surgery was on (b)(6) 2015.

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.There was nothing wrong the initial secure c implant.A decision was made by the surgeon to remove the existing core, and replace it with a larger cord which would provide additional distraction, and alleviate the patient discomfort.The explanted core was not returned for evaluation, due to hospital policy.

• Brand Name: SECURE-C CORE, 13X14, 7MM
• Type of Device: SECURE-C CORE
• 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: 4608458
• MDR Text Key: 5766663
• Report Number: 3004142400-2015-00011
• Device Sequence Number: 1
• Product Code: MJO
• 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: 02/13/2015

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: Health Professional
• Device Model Number: 414.207S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/13/2015
• 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: 35 YR
• Patient Weight: 165