MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM; QUARTEX 4.5MM POLYAXIAL SCREW, 26MM

Model Number	1149.4526
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during surgery part of a quartex 4.5mm polyaxial screw was broken and left in the patient's vertebra.This event occurred in austria. .
Additional Manufacturer Narrative
A partial quartex 4.5 polyaxial screw was availble for evaluation.Visual inspection confirms the shank head and screw head remain assembled, with the screw shank fractured at the neck.There is no visible wear and tear on locking cap threads.Since the part was returned fractured, investigation into shank dimensions and functionality of the assembled implant remains indeterminate at this time.The overall observed risk is low.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.No determinations could be made as to the cause of the reported issue.The following sections have been updated: b4; g6; h6; h10.
Event or Problem Description
It was reported that during surgery part of a quartex 4.5mm polyaxial screw was broken and left in the patient's vertebra.This event occurred in austria. .

• Brand Name: QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM
• Common Device Name: QUARTEX 4.5MM 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: 20906157
• Report Number: 3004142400-2024-00302
• Device Sequence Number: 13033415
• Product Code: NKG
• UDI-Device Identifier: 00889095355765
• UDI-Public: 00889095355765
• 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 1149.4526
• Device Lot Number: BAB038PA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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: Female