MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 4.75 THREADED 4.5 X 25MM POLYAXIAL SCREW, COCR HEAD, TI SHANK

Model Number	5067.1327
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the two screws of a growing rod construct (using marvel 4.75mm rods) had loosened over time and needed to be replaced with larger 6.5mm screws.No part or imaging was provided for evaluation.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.
Event or Problem Description
It was reported that a revision was needed to replace creo 4.75 threaded screws that were found loose post operatively.This event occurred in the united kingdom.

• Brand Name: CREO
• Common Device Name: CREO 4.75 THREADED 4.5 X 25MM POLYAXIAL SCREW, 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: 21026376
• Report Number: 3004142400-2024-00580
• Device Sequence Number: 9004188
• Product Code: NKB
• UDI-Device Identifier: 00889095261530
• UDI-Public: 00889095261530
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 12/23/2024

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: 5067.1327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/27/2024
• 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 Sex: Unknown