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

Model Number 5156.1745

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 336862967
• Report Number: 3004142400-2020-00059
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095788853
• UDI-Public: 00889095788853
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5156.1745
• Device Lot Number: BAX045NC, BAV932HB
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White