MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED PEDICLE SCREW

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation and no radiographic imaging was available for review.It's possible that implant selection, insertion technique, or incorrect use of instruments or imaging contributed to the reported issue.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported from a globus, belgium sales representative, that a creo pedicle screw was placed too straight and irritated the ls nerve.Revision was performed approximately three weeks post-operative to reposition the pedicle screw.

• Brand Name: CREO
• Type of Device: CREO THREADED PEDICLE 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: 18825615
• MDR Text Key: 336766872
• Report Number: 3004142400-2020-00051
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Date Manufacturer Received: 05/18/2020
• 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: 74 YR
• Patient Sex: Female
• Patient Race: White