MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SECURE C; SECURE C ENDPLATE & ASSEMBLY

Model Number 714.166S

Device Problem Expulsion (2933)

Patient Problem No Information (3190)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was returned for evaluation.A review was conducted of all applicable material records, manufacturing records, storage records, and distribution records according to the descriptions of the product used with the concomitant device.All records revealed all product lots were manufactured within specifications, maintained and distributed in accordance with all federal, state and operating procedures.Upon evaluation neither endplate elicit major damages, fractures, or signs of failure.The bearing surfaces of the superior and inferior endplates were clean with a polished appearance, and no damaged features.Bony deposits were observed on the bony apposition side of the superior endplate.Scratches were observed on the non bearing flange of both endplates consistent with surgical removal.The lateral view of the core showed loss of curvature of the superior bearing surface, biased towards the anterior aspect of the core.The superior aspect of the core showed mile circular deformation marks, as well as on the anterior inferior aspect of the core's bearing surface.Based on the current information available, it is not possible to determine the cause of the posterior expulsion of the secure c core.

Event Description

It was reported to globus that a patient had a revision surgery due to the secure c core having expulsed posteriorly.The initial surgery was performed (b)(6) 2015.The removal surgery was (b)(6) 2015.

Manufacturer Narrative

It was determined the implant date provided in the original report (3004142400-2015-00037) was incorrectly reported as (b)(6) 2015.The correct implant date is (b)(6) 2015.Sections have been updated from the original report to reflect this change.

Event Description

It was reported to globus that a patient had a revision surgery due to the secure c core having expulsed posteriorly.

• Brand Name: SECURE C
• Type of Device: SECURE C ENDPLATE & ASSEMBLY
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 5070187
• MDR Text Key: 25891832
• Report Number: 3004142400-2015-00037
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 714.166S
• Device Lot Number: GBP178DD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• 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: 45 YR