MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX; QUARTEX 4.5MM POLYAXIAL SCREW, 30MM

Model Number 1149.4530

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The device was returned for evaluation.Visual observation shows the top of the screw head being damaged/worn down, similarly to when a driver is mis-engaged atop the screw.The motion returned by the end of the surgery.Improper use of the driver may lead to the drive feature misaligning with the screw causing such damage; however, the exact cause of the reported issue could not be determined.

Event Description

It was reported that during a case the surgeon was removing a quartex screw attached to a driver.After screw removal the monitor indicated loss of motion in the patient's leg.

• Brand Name: QUARTEX
• Type of Device: QUARTEX 4.5MM 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: 14173592
• MDR Text Key: 289858462
• Report Number: 3004142400-2022-00058
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00889095355789
• UDI-Public: 00889095355789
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1149.4530
• Device Lot Number: BAX224JA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Race: White