MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM; QUARTEX 4.5MM POLYAXIAL SCREW, 30MM

Model Number	1149.4530
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging could be returned for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a surgery the implant broke and part of it was left inside patient.

• Brand Name: QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM
• Common Device Name: 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: 15945971
• Report Number: 3004142400-2022-00178
• Device Sequence Number: 6059648
• Product Code: NKG
• UDI-Device Identifier: 00889095355789
• UDI-Public: 00889095355789
• 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
• 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): 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1149.4530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 62 YR
• Patient Sex: Male