MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 7.5X45MM POLYAXIAL SCREW

Model Number	5119.1747
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation has not yet begun.No determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery took place to removed and replace a creo screw that fractured.This event took place in japan.
Event or Problem Description
It was reported that a revision surgery took place to removed and replace a creo screw that fractured.This event took place in japan.
Additional Manufacturer Narrative
A visual inspection of the returned part and the imaging provided confirms the reported issue.The patient is a 65-year-old male who previously underwent surgery on an unknown date for a tlif at l3/4 and posterior fixation at l3-l5.The initial surgery was completed with competitors' implants.On (b)(6) 2021, a revision surgery was completed due to adjacent segment disease (asd).During this revision surgery, the competitors' implants were removed and posterior fixation from l2-s1 was done with creo implants.In 2025, an x-ray was taken and showed that the patient had asd at l1/2, and the creo threaded 7.5x45mm polyaxial screw implanted at right s1 was fractured at the neck of the screw.On (b)(6) 2025, a second revision surgery was completed due to the asd at l1/2 and the fractured screw at right s1.During this revision surgery, the broken creo threaded 7.5x45mm polyaxial screw at right s1 was removed and additional posterior fixation was added to extend the construct to t10-sai with creo implants.A tlif was also completed at l1/2 to implant a rise spacer.Reviewing the related dhr shows the item was stated to be manufactured from the correct material.Due to the inability to replicate surgical conditions and forces experienced by the screws post-op, the exact cause of the failure cannot be determined.Product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.The following sections were updated for this supplemental report: b4, d9, g6, h2, h6, h10.

• Brand Name: CREO
• Common Device Name: CREO THREADED 7.5X45MM 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: 22854030
• Report Number: 3004142400-2025-00178
• Device Sequence Number: 4419001
• Product Code: MNH
• UDI-Device Identifier: 00889095104721
• UDI-Public: 00889095104721
• 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: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 5119.1747
• Device Lot Number: BAY262MH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/19/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Race: Asian