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

Model Number	1149.0001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The two locking caps that loosened post operatively were returned for evaluation.Visual observation shows no indentations/deformations indicative of being final tightened.The other eleven locking caps from the construct that did not loosen were also returned.Two of these do not have any indentations/deformations and the two others have extremely faint indentations indicative of being final tightened.Seven caps appear to have been torqued out properly and have the full indentation/deformation along the bottom surface.No determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was completed for 2 quartex threaded locking caps that loosened at c2 and c3, 2 months post operatively.

• Brand Name: QUARTEX
• Common Device Name: 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: 14112809
• Report Number: 3004142400-2022-00055
• Device Sequence Number: 6108444
• Product Code: NKG
• UDI-Device Identifier: 00889095354492
• UDI-Public: 00889095354492
• 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: 2022
• Device Explanted Year: 2022
• 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): 04/08/2022

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: 1149.0001
• Device Lot Number: BAY498SB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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