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

Device Problem Unintended Movement (3026)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

The device was not available for evaluation.The imaging provided shows one screw and locking cap visible at t12 and a small portion of a locking cap visible through soft tissue at t11.The reported issue describes post-operative adhesion of soft tissue to the implants and subsequent rupture of tissue resulting in bleeding.Post-operative scarring and tissue adhesion to implant devices and within the thoracic space is a known risk of anterior approaches to the thoracic spine, as is the risk of soft tissue contact with metal devices.Individual anatomy and the specific levels instrumented may also play a role in these potential risks.

Event Description

It was reported by a representative from (b)(6) that 4 weeks post-operatively a patient experienced adverse effects when a screw penetrated the lung and an adhesion from the screw ruptured, resulting in severe bleeding.

• Brand Name: CREO
• Type of Device: CREO SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 12333415
• MDR Text Key: 267024151
• Report Number: 3004142400-2021-00158
• 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: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• 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