MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5, 6.5 X 45MM HA COATED POLYAXIAL SCREW,

Model Number	5119.1464S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the devices or any imaging were available for evaluation.It's possible that improper positioning of the implants, bony fracture, or facet join disruption or disease could have contributed to the observed pain.However, the exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported the patient complained of "clicking" and right sided pain.Post-operative ct imaging showed all screws, rods, and caps to be intact.However, the right s1 and ls screws appeared to be slightly lateral and long.Revision surgery was needed to reposition the screws.

• Brand Name: CREO
• Common Device Name: CREO 5.5, 6.5 X 45MM HA COATED 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: 18831346
• Report Number: 3004142400-2019-00030
• Device Sequence Number: 2957855
• Product Code: MNH
• UDI-Device Identifier: 00889095212723
• UDI-Public: 00889095212723
• 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
• Device Explanted 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5119.1464S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2019
• 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: 58 YR
• Patient Sex: Female
• Patient Race: White