MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; SELF-RETAINING DRIVER SHAFT, 1/4" QUICK-CONNECT

Model Number	6067.0060
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Initial observation of the returned device shows the tip deformed and fractured.The tip bends in a way that signifies that something was being loosened.The fracture may have occurred if the self retaining driver was not fully seated within the screw making it more likely to break during tightening and/or loosening; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that during surgery the tip of the creo self-retaining driver shaft was broken and left in the patient.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: SELF-RETAINING DRIVER SHAFT, 1/4" QUICK-CONNECT
• 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: 18821980
• Report Number: 3004142400-2023-00044
• Device Sequence Number: 4526308
• Product Code: LXH
• UDI-Device Identifier: 00889095167979
• UDI-Public: 00889095167979
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/01/2024

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: 6067.0060
• Device Lot Number: VIT342AE*F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 134 KG
• Patient Race: White