MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS LOCKING CAP

Model Number 1134.0010

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2022

Event Type  malfunction  

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.

Event Description

It was reported that a creo mis locking cap is loose with subsequent rod migration and patient is experiencing symptoms 7 months post operatively.This event occurred in japan.

• Brand Name: CREO
• Type of Device: CREO MIS LOCKING CAP
• 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: 15845337
• MDR Text Key: 304829697
• Report Number: 3004142400-2022-00170
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2022

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: 1134.0010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/22/2022
• 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 Sex: Male
• Patient Race: Asian