MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X40MM POLYAXIAL SCREW

Model Number	5119.1642
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.It was reported that two creo threaded 6.5x40mm polyaxial screws fractured in the s1 pedicles.Images returned show that the reported fracture occurred in both s1 screws about 1/3 of the screw length from the proximal side.The initial surgery was a posterior lateral fusion from l4-s1 and is reported to have occurred on (b)(6) 2022.The patient had an l5-s1 alif performed on (b)(6) 2023 with hedron ia because she refused posterior surgery.A follow up evaluation showed that one of the hedron ia locking screws backed out.This prompted the surgeon to replace the fractured s1 screws.These fractures are indicative of high forces or repetitive stresses being placed on the screws and a lack of fusion over time, however, it is unknown exactly how this failure may have occurred.Only images were returned, so the full scope of the patient's applicable anatomy and the wear shown on each screw is unknown.The surgical and post-operative conditions cannot be replicated.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed due to creo threaded screws that were found broken post operatively. .

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5X40MM POLYAXIAL SCREW
• 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: 18810545
• Report Number: 3004142400-2023-00197
• Device Sequence Number: 3338262
• Product Code: MNH
• UDI-Device Identifier: 00889095104127
• UDI-Public: 00889095104127
• 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): 02/29/2024

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: 5119.1642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 02/29/2024
• 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: Unknown