MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO FENESTRATED SCREW SYSTEM; CREO FENESTRATED, MIS LOCKING CAP

Model Number 1192.0020

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that a revision surgery was needed to replace creo fenestrated mis locking caps that were found loose post operatively. .

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.There is evidence of wear on the bottoms of the caps, which is normal and likely due to friction from the cap/rod interference while locking it down.Minor scuff marks were observed on the top of the caps.No additional visual wear was detected on either cap.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO FENESTRATED SCREW SYSTEM
• Type of Device: CREO FENESTRATED, MIS LOCKING CAP
• 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: 18837353
• MDR Text Key: 337024220
• Report Number: 3004142400-2023-00095
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172269
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1192.0020
• Device Lot Number: BAB001FA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• 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 Sex: Female
• Patient Weight: 89 KG