MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5, 7.5X40MM POLYAXIAL SCREW

Model Number	5119.1740
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it remains in the patient.It's possible that the reported fall was either the cause or a contributing factor to the screw head disassociating from the shank as the patient was not experiencing any adverse effects prior.However, the exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that the patient was experiencing pain following a one foot fall.Imaging taken after the fall show one of the s1 screw heads has disassociated from the shank.

• Brand Name: CREO
• Common Device Name: CREO 5.5, 7.5X40MM 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: 18829632
• Report Number: 3004142400-2019-00038
• Device Sequence Number: 19575778
• Product Code: MNH
• UDI-Device Identifier: 00889095104684
• UDI-Public: 00889095104684
• 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: 2019
• 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): 03/04/2024

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: 5119.1740
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 03/04/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White