MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO AMP THREADED POLYAXIAL TULIP

Model Number 1119.0110

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows minor signs of wear to the thread features and bottom contacting surface of the locking caps.This is consistent with inadequate final tightening of the implants.The imaging provided confirmed several caps back-out at the top of the construct, where the rods and locking caps had dissociated from the screws.It is possible that the locking caps were not sufficiently final tightened due to the lack of surface and thread wear, however, the exact cause of the reported issue could not be determined.

Event Description

It was reported there was a revision due to creo amp threaded polyaxial screw heads backing out of a construct post operatively.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO AMP THREADED POLYAXIAL TULIP
• 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: 18834300
• MDR Text Key: 336871816
• Report Number: 3004142400-2023-00084
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059656
• UDI-Public: 00889095059656
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0110
• Device Lot Number: BAA681LG/BAA276HG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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 Sex: Female