MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 7.5X40MM POLYAXIAL SCREW

Model Number 5119.1742

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Initial observation shows no visible damage to the screw.From the information provided, it may be assumed that the screw was seen post operatively protruding through the lateral side of the pedicle because the revision surgery was described as revising the trajectory.Because no imaging was available for evaluation, an exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was needed to replace a creo threaded screw that had found to be projected though the bone post operatively.This event occurred in japan.

• Brand Name: CREO
• Type of Device: CREO THREADED 7.5X40MM POLYAXIAL 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: 15300010
• MDR Text Key: 304828389
• Report Number: 3004142400-2022-00128
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095104691
• UDI-Public: 00889095104691
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1742
• Device Lot Number: BAY049FH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Race: Asian