MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM; QUARTEX 3.5MM POLYAXIAL SHOULDER SCREW, 26MM

Model Number 1149.3726

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that quartex screws were found broken at c1 post operatively.There is no revision planned.This event occurred in japan.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.No determinations could be made as to the cause of the reported issue.The following sections have been updated.B4, e1, h2, h6, h10.

• Brand Name: QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM
• Type of Device: QUARTEX 3.5MM POLYAXIAL SHOULDER 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: 18834239
• MDR Text Key: 336856926
• Report Number: 3004142400-2023-00063
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00889095354980
• UDI-Public: 00889095354980
• 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: 03/01/2024

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: 1149.3726
• Device Lot Number: BAV494WA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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 Race: Asian