MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 5.5X45MM MODULAR CANNULATED SCREW

Model Number	1067.4545
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it was discarded by the hospital.Lma.Glng taken six days post-operative appear to show a slight lateral breach of the left ls screw.During investigation, it was stated that there was difficulty placing the ls screws with the robot and the surgeon was advised to re-plan the screw trajectory but declined and the screws were verified lo be place according lo plan.There was no system or device malfunction.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported from a representative in ireland that the patient was experiencing localized left side and left leg pain post­ operatively.Imaging showed a slight lateral breach of the left l5 screw.Revision surgery was performed to remove the screw.

• Brand Name: CREO
• Common Device Name: CREO AMP 5.5X45MM MODULAR CANNULATED 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: 18823401
• Report Number: 3004142400-2020-00039
• Device Sequence Number: 20628323
• Product Code: MNH
• UDI-Device Identifier: 00889095023497
• UDI-Public: 00889095023497
• 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: 2020
• Device Explanted Year: 2020
• 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): 03/02/2024

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: 1067.4545
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/02/2024
• 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: 51 YR
• Patient Sex: Female
• Patient Race: White