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

Model Number 1119.0010

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2023

Event Type  malfunction  

Event Description

It was reported that during an extension surgery (2) creo threaded locking caps were found loose post operatively.This event occurred in japan.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Two locking caps were returned for evaluation.Initial observation shows visible burrs around the bottom threads of one of the locking caps and no visible deformation around the other.It's possible that the deformation of the locking cap could be due to cross threading and excessive forces; however, an exact cause of the reported issue could not be determined.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO THREADED 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: 18820683
• MDR Text Key: 336796054
• Report Number: 3004142400-2023-00039
• Device Sequence Number: 1
• Product Code: MNH
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0010
• Device Lot Number: BAX315AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• 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
• Patient Race: Asian