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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2020

Event Type  Injury  

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.Given the amount of time the device was implanted, the observed issue is consistent with there being an insufficiency of high quality bone within the vertebrae to promote bone regrowth and fusion.However, the exact cause of the reported issue cannot be determined.

Event Description

It was reoorted that the l5 creo pedicle screw loosened within the patient's bone approximately two years post-operatively.

• Brand Name: CREO
• Type of Device: CREO 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: 18826040
• MDR Text Key: 336776913
• Report Number: 3004142400-2020-00056
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2020
• 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 Race: Asian