MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 7.5X50MM MODULAR SCREW

Model Number 1067.1750

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it was discarded by the hospital.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that two creo screws had loosened post-operatively requiring revision surgery.

• Brand Name: CREO
• Type of Device: CREO AMP 7.5X50MM MODULAR 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: 18828309
• MDR Text Key: 336811501
• Report Number: 3004142400-2019-00041
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095016949
• UDI-Public: 00889095016949
• 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: 1067.1750
• Date Manufacturer Received: 05/17/2019
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Race: White