MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX; QUARTEX 3.5MM POLYAXIAL SCREW, 10MM

Model Number 1149.3510

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2018

Event Type  malfunction  

Event Description

A revision surgery was needed to remove a quartex screw from c3 that had loosened.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Based on the information received, it appears that the patient did not follow protocol upon recovery.The sales representative stated that the patient did not wear her cervical collar which may have led to the screw loosening.However, no part was received to further analyze.The exact cause of the reported issue cannot be determined.

• Brand Name: QUARTEX
• Type of Device: QUARTEX 3.5MM POLYAXIAL SCREW, 10MM
• 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: 18815620
• MDR Text Key: 336873750
• Report Number: 3004142400-2018-00016
• Device Sequence Number: 1
• Product Code: NKG
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1149.3510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2018
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White