MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 5.5X45MM POLYAXIAL SCREW

Model Number 5119.1547

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it was discarded by the hospital.The most likely cause of the reported issue is due to implant selection and insertion technique.However, the exact cause cannot be determined.

Event Description

It was reported that post-operative imaging showed that the right l3 creo pedicle screw was not placed properly.Revision surgery was performed to reposition.

• Brand Name: CREO
• Type of Device: CREO THREADED 5.5X45MM 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: 18825830
• MDR Text Key: 336817800
• Report Number: 3004142400-2020-00055
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095103588
• UDI-Public: 00889095103588
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5119.1547
• Device Lot Number: BAV321KH
• Date Manufacturer Received: 06/03/2020
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Race: Asian