MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 8.5 X 80MM MODULAR SCREW

Model Number 1067.1880

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The two screws were returned with a fracture at the neck of the screw head.The screws were inspected and all relevant dimensions were determined to be within specification.No determination can be made as to the cause of the reported issue.Additional product codes for this device are kwq, nk8, mni, kwp, and osh.

Event Description

Images taken (b)(6) 2017 show breakage of two s2 creo screws just below the screw head.Revision surgery was performed to remove and replace the screws.

• Brand Name: CREO
• Type of Device: 8.5 X 80MM MODULAR 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: 18811570
• MDR Text Key: 336815905
• Report Number: 3004142400-2017-00073
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1067.1880
• Device Lot Number: CWP262MA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2013
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White