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

Model Number	1156.0010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the creo dlx locking cap had loosened approximately one week post-operatively.

• Brand Name: CREO DLX
• Common Device Name: 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
• Report Number: 3004142400-2020-00058
• Device Sequence Number: 19575882
• Product Code: NKB
• UDI-Device Identifier: 00889095782547
• UDI-Public: 00889095782547
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1156.0010
• Device Lot Number: BAW524SC, BAW543LC
• 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