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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.Additional information provided that the patient had weak bone quality.During a t10-sacrum fusion there can be a lot of stress seen on the screws and rod as it fights the anatomy to achieve correction over a long construct.These stresses can be excessive depending on the bone quality of the patient.However an exact cause of the reported issue could not be determined.

Event Description

It was reported that during surgery creo amp screws installed at left l1-l5 loosened and dislodged when after tightening of s1 and sai screws.This event occurred in japan.

• Brand Name: CREO
• Type of Device: CREO 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: 18820375
• MDR Text Key: 336808429
• Report Number: 3004142400-2023-00038
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2023
• 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