MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 6.5X45MM MODULAR CANNULATED SCREW

Model Number 1067.4645

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging was available for evaluation.No determinations could be made as to the cause.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

Event Description

It was reported that the pedicle screw was not placed properly.Revision surgery was performed to reposition the screw.

• Brand Name: CREO
• Type of Device: CREO AMP 6.5X45MM 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: 18827352
• MDR Text Key: 336793038
• Report Number: 3004142400-2020-00067
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095023688
• UDI-Public: 00889095023688
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1067.4645
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 03/04/2024
• 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: Asian