MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO AMP THREADED POLYAXIAL TULIP

Model Number	1119.0110
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows minor signs of wear to the thread features and bottom contacting surface of the locking caps.This is consistent with inadequate final tightening of the implants.The imaging provided confirmed several caps back-out at the top of the construct, where the rods and locking caps had dissociated from the screws.It is possible that the locking caps were not sufficiently final tightened due to the lack of surface and thread wear, however, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported there was a revision due to creo amp threaded polyaxial screw heads backing out of a construct post operatively.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: CREO AMP THREADED POLYAXIAL TULIP
• 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: 18834300
• Report Number: 3004142400-2023-00084
• Device Sequence Number: 18001990
• Product Code: MNH
• UDI-Device Identifier: 00889095059656
• UDI-Public: 00889095059656
• 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): 03/02/2024

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: 1119.0110
• Device Lot Number: BAA681LG/BAA276HG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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