MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 8.5X80MM POLYAXIAL SCREW,

Model Number 5119.1882

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.Images show the screw head detached from the screw shank and slipped from the rod.The exact cause of the reported issue could not be determined.

Event Description

It was reported that the screw head detached from the screw 3 days post-operatively.

• Brand Name: CREO
• Type of Device: CREO THREADED 8.5X80MM 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: 18816854
• MDR Text Key: 336818023
• Report Number: 3004142400-2020-00084
• Device Sequence Number: 1
• Product Code: MNH
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5119.1882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female