MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO DLX; CREO DLX POLYAXIAL SCREW, 7.5X45MM

Model Number	5156.1745
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned screws found signs of wear due to tightening and head manipulation.In addition, the top thread of on screw was found to have its first thread damaged.Imaging provided show the construct to not have lost stability.It's possible tha poor bone quality, and/or excessive force may have contributed to he reported issue.However, the exact cause cannot be determined.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that the creo dlx polyaxial screws had pulled out of the patient's bone approximately one week post­ operatively.

• Brand Name: CREO DLX
• Common Device Name: CREO DLX POLYAXIAL SCREW, 7.5X45MM
• 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: 18826421
• Report Number: 3004142400-2020-00059
• Device Sequence Number: 2970884
• Product Code: NKB
• UDI-Device Identifier: 00889095788853
• UDI-Public: 00889095788853
• 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: 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): 03/04/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5156.1745
• Device Lot Number: BAX045NC, BAV932HB
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Female
• Patient Race: White