MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; THREADED LOCKING CAP DRIVER

Model Number 6120.5000

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

It was reported that the surgeon used the correct locking cap driver to implant the creo amp threaded end cap.He passed it through the counter torque, into the 20mm reduction tulips, and began tightening the end cap into the construct.Upon removing the driver from the initial tightening he noticed the tip of the screwdriver had broken off in the end cap.Surgeon attempted to remove the broken piece, however it sat flush inside the end cap.No adhesive or instrument was able to remove it and the broken screwdriver tip was left within the end cap.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The instrument was returned for evaluation and it was confirmed that the driver tip had sheared off.It is possible the driver may have experiencedexcessive forces or torque during implantation.However, the exact cause of the reported issue cannot be determined.The following sections have been updated for this supplemental report: b4, e1, g6, h2, h6, h10.

• Brand Name: CREO
• Type of Device: THREADED LOCKING CAP DRIVER
• 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: 18809726
• MDR Text Key: 337309760
• Report Number: 3004142400-2019-00050
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6120.5000
• Device Lot Number: VIT126CB
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other