MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO AMP® 5.5 X 45MM MODULAR CANNULATED SCREW

Model Number 1067.4545

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Spinal Cord Injury (2432)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it was discarded by the hospital.It's stated that the screw was placed too far medial, which indicates improper placement of the screw and not a malfunction of the implant.

Event Description

It was reported that a creo mis screw had been placed too medial and had breached the medial wall of the pedicle.The patient experienced left sided numbness and a revision surgery was performed to remove the screw.

• Brand Name: CREO MIS
• Type of Device: CREO AMP® 5.5 X 45MM MODULAR CANNULATED SCREW
• 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: 18832134
• MDR Text Key: 336873026
• Report Number: 3004142400-2018-00056
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095023497
• UDI-Public: 00889095023497
• 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: 03/04/2024

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1067.4545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• 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
• Patient Sex: Female
• Patient Race: White