MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO DLX; CREO DLX THREADED LOCKING CAP

Model Number 1156.0010

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned locking caps and rod was performed.The threads had signs of wear to due possible edge loading.It's possible that micro-motion within the construct due to the construct pulling out of bone, as well as extreme bends seen in the rod causing the locking caps to be edge loaded and not locking appropriately may have contributedto the reported issue.However, the exact cause cannot be determined.

Event Description

It was reported that the creo dlx locking cap had loosened approximately one week post-operatively.

• Brand Name: CREO DLX
• Type of Device: CREO DLX THREADED LOCKING CAP
• 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: 18826161
• MDR Text Key: 336873192
• Report Number: 3004142400-2020-00058
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095782547
• UDI-Public: 00889095782547
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1156.0010
• Device Lot Number: BAW524SC, BAW543LC
• 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