MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; THREADED LOCKING CAP DRIVER

Model Number	6120.5000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation of the device shows the tip fractured in a clockwise manner which is consistent with inserting an implant.Additional information provided that the surgeon had trouble getting the first locking cap down so they took it out and inserted another.The set screw that caused the issue was inserted all the way when the locking cap driver broke at the tip within the locking cap.The set screw and the driver tip were left in the patient, as the driver tip could not be removed.The screw head that was being used was a tav creo amp threaded screw head.It is possible that the threads within the screw head became cross threaded during the insertion of the locking cap which could have caused the excessive friction that lead to difficulty inserting both set screws.Additional information provided that the difficulty could have stemmed from not bending the rod before insertion.The fracture of the driver tip is consistent with excessive stress; 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 threaded locking cap driver was broken and left in a set screw in the patient.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: THREADED LOCKING CAP DRIVER
• 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: 18834285
• Report Number: 3004142400-2023-00076
• Device Sequence Number: 7438964
• Product Code: LXH
• UDI-Device Identifier: 00889095173604
• UDI-Public: 00889095173604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• 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): 03/02/2024

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: 6120.5000
• Device Lot Number: VIV052BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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 Age: 64 YR
• Patient Sex: Male