MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS STABILIZATION SYSTEM; CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION

Model Number	1134.0100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a revision was needed for a creo mis modular polyaxial tulip that had broken post operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it was discarded by the hospital.The imaging provided shows considerable correction attempted on the s1 vertebral body.Head pull-off may occur due to excessive forces, or incorrect attachment of the screw head using a head inserter; however, no determinations could be made as to the cause of the reported issue.The following sections have been updated.B4, e1, h2, h6, h10.

• Brand Name: CREO MIS STABILIZATION SYSTEM
• Common Device Name: CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION
• 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: 18837558
• Report Number: 3004142400-2023-00102
• Device Sequence Number: 12633878
• Product Code: MNH
• UDI-Device Identifier: 00889095071146
• UDI-Public: 00889095071146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 03/04/2024

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: 1134.0100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 03/05/2024
• 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 Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Hispanic