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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported that a revision surgery was performed due to patient pain and found creo screw heads were loose at t11 left and l3 left.This event took place in indonesia.

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Type of Device: CREO THREADED POLYAXIAL TULIP
• 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: 15128203
• MDR Text Key: 302339644
• Report Number: 3004142400-2022-00116
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2022
• 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