MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5, 7.5X40MM POLYAXIAL SCREW

Model Number 5119.1740

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

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 remains in the patient.It's possible that the reported fall was either the cause or a contributing factor to the screw head disassociating from the shank as the patient was not experiencing any adverse effects prior.However, the exact cause of the reported issue cannot be determined.

Event Description

It was reported that the patient was experiencing pain following a one foot fall.Imaging taken after the fall show one of the s1 screw heads has disassociated from the shank.

• Brand Name: CREO
• Type of Device: CREO 5.5, 7.5X40MM POLYAXIAL 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: 18829632
• MDR Text Key: 336812034
• Report Number: 3004142400-2019-00038
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095104684
• UDI-Public: 00889095104684
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1740
• Date Manufacturer Received: 04/26/2019
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White