MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. DEVICE ONE: SECURE-C ENDPLATE ASSEMBLY, 14X16

Model Number 714.306S

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

Additional device: secure-c core, 14x16, 7m, model#: 413.307s.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.The explanted secure c endplate assembly was measured and found to be within specifications.Evaluation of the superior endplate and inferior endplate elicit no major damages, fractures, or signs of any failure.The bearing surfaces on both endplates were clean with a few heavy scratches.The anterior non bearing flange of both endplates showed signs of heavy scratching.The posterior regions of both endplates were clean with minimal scratches.The bony apposition side of both endplates exhibited missing plasma spray near the anterior portion.The scratches on both endplates bearing and non bearing surfaces and the loss of material on the bony apposition side are consistent with tools used during removal process.Dimensional measurements were performed on the core, and two of the three were within specifications.The anterior/posterior length was out of tolerance due to the anterior lip of the core being torn apart during removal.The superior aspect of the core showed a deep scratch on the antero-lateral side.The inferior aspect showed minimal scratches and damage.The anterior non bearing flange showed signs of severe bite marks consistent with the use of surgical tools during removal.The recess features on the inferior aspect showed minimal signs of deformation.The lateral non bearing flange on both aspects had minimal scratches.The posterior flange on both aspects had minimal signs of damage.The scratches on the core are consistent with the use of surgical tools during removal.The cause of the removal is not related to the implant function.Based on the information provided, the cause of the removal was due to patient pain, and the removal is not related to implant function.The secure-c implant is comprised of two parts, i.E.Part number 714.306s secure-c endplate assembly, and part number 413.307s secure-c core.These two parts combined make up the secure c implant.

Event Description

It was reported to globus that a patient had a revision surgery to remove a secure c implant due to pain.The removal surgery took place (b)(6) 2015.

• Brand Name: DEVICE ONE: SECURE-C ENDPLATE ASSEMBLY, 14X16
• Type of Device: SECURE-C ENDPLATE ASSEMBLY
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave.; audubon PA 19403
• Manufacturer Contact: daniel paul, vp, qa and it ; 2560 general armistead ave.; audubon, PA 19403 ; 6109301800
• MDR Report Key: 5254298
• MDR Text Key: 32351437
• Report Number: 3004142400-2015-00046
• Device Sequence Number: 1
• Product Code: KWP
• 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: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 714.306S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 39 YR