MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX; QUARTEX THREADED LOCKING CAP

Model Number 1149.0001

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The devices were not available for evaluation as they remain in the patient.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that the set screw on the locking cap has backed out post-operatively.A revision is not scheduled.

• Brand Name: QUARTEX
• Type of Device: QUARTEX THREADED 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: 18832597
• MDR Text Key: 336829802
• Report Number: 3004142400-2018-00066
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00889095354492
• UDI-Public: 00889095354492
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1149.0001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 03/04/2024
• 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