MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO AMP 8.5X80MM MODULAR CANNULATED SCREW

Model Number 1067.4880

Device Problems Mechanics Altered (2984); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 02/02/2023

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 during a revision surgery 3 creo threaded 6.5x45mm polyaxial screws at t11/t12 and 3 creo amp 8.5x80mm modular cannulated screws at the illiac were found loose post operatively.This event occurred in (b)(6).

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO AMP 8.5X80MM MODULAR CANNULATED 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: 16546149
• MDR Text Key: 311334533
• Report Number: 3004142400-2023-00028
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095024135
• UDI-Public: 00889095024135
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1067.4880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• 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