MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO THREADED 6.5X40MM REDUCTION SCREW

Model Number 5119.6640

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2021

Event Type  malfunction  

Event Description

It was reported that a revision surgery was done to remove a creo threaded screw that had broken post operatively.This event occurred in (b)(6).

Manufacturer Narrative

A post-operative image of the hardware showed that the screw head dissociated from the screw shank as well as the two clamp halves.No post-operative imaging was available and the part was not returned for further evaluation.The exact cause of the reported issue could not be determined.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO THREADED 6.5X40MM REDUCTION 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 ; 6109301822
• MDR Report Key: 12683117
• MDR Text Key: 281129134
• Report Number: 3004142400-2021-00203
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095120578
• UDI-Public: 00889095120578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D201515
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.6640
• Device Lot Number: JNW232NJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2019
• 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