MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO FENESTRATED, MIS LOCKING CAP

Model Number 1192.0020

Device Problem Use of Device Problem (1670)

Patient Problem Spinal Column Injury (2081)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The x-rays were taken after the patient had complained of pain.Imaging confirmed that the left locking caps at l3 and l4 started to become unthreaded and the right ones were no longer within the tulip.It could not be determined if the locking caps at l1-t12 were loose based on the returned images.There was no information on post operative conditions and whether there was any trauma or excessive forces placed on the construct.Because surgical and post-op conditions could not be replicated, the cause of the complaint could not be established.

Event Description

It was reported that a revision surgery was needed to replace creo fenestrated screws that were found loose causing patient pain post operatively.This event occurred in germany.

• Brand Name: CREO
• Type of Device: CREO FENESTRATED, MIS LOCKING CAP
• 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: 18827392
• MDR Text Key: 336873625
• Report Number: 3004142400-2024-00008
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172269
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1192.0020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• 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