MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X45MM REDUCTION SCREW

Model Number	5119.6645
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part was not available for evaluation.It was reported that a revision surgery was needed to replace creo screws that were found broken post operatively.This was a patient with a previous level fusion l4-s1.L4-l5 had fused but had a non-union at l5-s1 and screw breakage in the left side of construct.The screws were short into the s1 which could aid to the screw breakage as well as no interbody implant in l5-s1.A revision surgery was performed with a rise interbody implant as well as longer s1 ha creo screws.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was needed to replace creo screws that were found broken post operatively.This event occurred in ireland.

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5X45MM REDUCTION 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: 18517644
• Report Number: 3004142400-2024-00011
• Device Sequence Number: 17830396
• Product Code: MNH
• UDI-Device Identifier: 00889095120592
• UDI-Public: 00889095120592
• 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 Explanted Year: 2023
• 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): 01/12/2024

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: 5119.6645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/16/2024
• 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