MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX; QUARTEX 3.5MM POLYAXIAL SCREW, 26MM

Model Number 1149.3526

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

It was reported that about 8 weeks post-operatively, the patient turned their head and heard a "pop" sound.They went in for a follow up visit and imaging showed that one of the screw shanks was broken.There is no plan for a revision at this time.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Upon visual evaluation of the x-rays provided, it appears as though the screw shank sheared at the shaft.No revision of the part was done and further evaluation could not be done.Based on the information received, the exact cause of the reported issued cannot be determined.The following sections have been updated: b4, e1, e3, h2, h6, h10.

• Brand Name: QUARTEX
• Type of Device: QUARTEX 3.5MM POLYAXIAL SCREW, 26MM
• 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: 18815344
• MDR Text Key: 336629802
• Report Number: 3004142400-2018-00013
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161591
• 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: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1149.3526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR