MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 5.5X45MM POLYAXIAL SCREW

Model Number 5119.1546

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the implant or imaging were available for evaluation.It is possible poor bone quality due to cancer and/or excessive force placed on the implant during unknown patient loading may have contributed to the reported issue.However, the exact cause cannot be determined.

Event Description

It was reported the l3 screw pulled out of bone post-operatively.The patient reportedly has poor bone quality due to previously having cancer.

• Brand Name: CREO
• Type of Device: CREO THREADED 5.5X45MM 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: 18823388
• MDR Text Key: 336873339
• Report Number: 3004142400-2020-00026
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095103588
• UDI-Public: 00889095103588
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1546
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/02/2024
• 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 Age: 71 YR