MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO DLX POLYAXIAL SCREW , 8.5X100MM

Model Number	5156.1800/5156.1801
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed to remove (2) creo dlx screws broken post operatively.
Additional Manufacturer Narrative
The device could not be returned for evaluation.The imaging provided shows bilateral breakage of the neck of the screw shank.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: CREO DLX POLYAXIAL SCREW , 8.5X100MM
• 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: 16111371
• Report Number: 3004142400-2023-00001
• Device Sequence Number: 14888801
• Product Code: NKB
• UDI-Device Identifier: 00889095789072
• UDI-Public: 00889095789072
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2022

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: 5156.1800/5156.1801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 01/06/2023
• 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