MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 8.0-6.5X85MM DOD SCREW

Model Number	5119.2287
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a creo threaded screw head was found to be loose post operatively.
Additional Manufacturer Narrative
The lateral x-ray showed that one of the rods had a large bend right above the s1 screws.It was not confirmed if the rod was inserted with this bend or not.This exaggerated angle may have put excessive force on the anchoring s1 screw, however, because these forces and surgical conditions cannot be replicated the exact cause of pull off cannot be determined.No other additional information was provided for examination.The observed overall risk level is low, which matches the observed anticipated risk level; therefore, the overall risk of the system has been maintained.No determinations could be made to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: CREO THREADED 8.0-6.5X85MM DOD 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: 20750468
• Report Number: 3004142400-2024-00281
• Device Sequence Number: 4399684
• Product Code: MNH
• UDI-Device Identifier: 00889095108361
• UDI-Public: 00889095108361
• 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: 2024
• 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): 11/21/2024

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: 5119.2287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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