MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; 4.75MM CURVED ROD, COBALT CHROME, 60MM LENGTH

Model Number	6123.1050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the surgery, the distal tip of the 5.0mm tap fractured while tapping the right l5 pedicle.The tap was approximately 30mm deep in the pedicle when the fracture occurred.The surgery was extended 2 hours; however, the broken tip of the tap was removed from the patient.N.The sales representative stated that the patient had sclerotic bone.The observed overall risk is low, which does not exceed the observed anticipated risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.The cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that the tip of a 5.0mm tap was broken and the procedure was extended 2 hours to retrieve the tip.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: 4.75MM CURVED ROD, COBALT CHROME, 60MM LENGTH
• 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: 21355696
• Report Number: 3004142400-2025-00023
• Device Sequence Number: 15704044
• Product Code: OLO
• UDI-Device Identifier: 00889095196238
• UDI-Public: 00889095196238
• 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: 2025
• Device Explanted Year: 2025
• 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): 02/11/2025

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: 6123.1050
• Device Lot Number: BTW016DC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• 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: 57 YR
• Patient Sex: Male