MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO PREFERRED ANGLE SCREW, 8.5-7.0X80MM, CANNULATED, DOD, COCR HEAD, TI SHANK

Model Number	7218.7880
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.Based on the x-rays, the screw fractured at the neck just below the proximal end.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a creo preferred angle screw was found broken post operatively.

• Brand Name: CREO
• Common Device Name: CREO PREFERRED ANGLE SCREW, 8.5-7.0X80MM, CANNULATED, DOD, COCR HEAD, TI SHANK
• 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: 21607828
• Report Number: 3004142400-2025-00039
• Device Sequence Number: 18332106
• Product Code: KWP
• UDI-Device Identifier: 00193982065805
• UDI-Public: 00193982065805
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/14/2025

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: 7218.7880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/14/2025
• 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 Age: 78 YR
• Patient Sex: Female