MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX; QUARTEX 4.0MM POLYAXIAL SCREW, 30MM

Model Number	1149.4030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation.The quartex screw fractured at the shank neck while the surgeon was adjusting its position using the "stab and grab" quartex driver.The surgeon used the hospital's own removal set and attempted to remove the shank.The confirmed that while attempting to remove the shank, the vertebral artery was damaged and a bleed resulted.The case was aborted, patient stabilized, and later the construct was extended to the occiput.The event evaluation form described that there was serious patient effect.This, as well as the description of the event, leads to an observed severity of moderate which is within the expected risk level.
Event or Problem Description
It was reported that a quartex screw fractured under the screw head, while trying to remove the fractured screw the vertebral artery was damaged and the case was aborted.

• Brand Name: QUARTEX
• Common Device Name: QUARTEX 4.0MM POLYAXIAL SCREW, 30MM
• 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: 23042474
• Report Number: 3004142400-2025-00201
• Device Sequence Number: 13234104
• Product Code: NKG
• UDI-Device Identifier: 00889095355215
• UDI-Public: 00889095355215
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 1149.4030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown