MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM; QUARTEX 4.5MM POLYAXIAL SCREW, 22MM

Model Number	1149.4522
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlie the device could not be returned for evaluation.The imaging provided shows the ø4.5x22mm quartex polyaxial screw at the bottom of the construct (t1) had fractured at the neck of the screw.Additional information provided that the patient had an existing construct from c3-c7, backing up a cervical plate.The patient suffered a fall, causing the c7 vertebra to collapse.The surgeon brought the patient back in to extend the construct to t1.During the procedure to extend the construct the screws were placed in a neutral position, meaning there was no extreme head angulation.There was also no use of reduction in the procedure.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a quartex 4.5mm polyaxial screw has broken post operatively.

• Brand Name: QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM
• Common Device Name: QUARTEX 4.5MM POLYAXIAL SCREW, 22MM
• 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: 18821699
• Report Number: 3004142400-2023-00043
• Device Sequence Number: 11906992
• Product Code: NKG
• UDI-Device Identifier: 00889095355741
• UDI-Public: 00889095355741
• 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: 2023
• 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): 03/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1149.4522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/01/2024
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Race: Asian