MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; SURGICAL SCREWDRIVER, REUSABLE

Model Number	6067.0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of tip damage.Visual inspection of the attached images confirmed the reported issue.Based on the details provided, a l2-l4 posterior fusion was completed on (b)(6) 2025 with creo implants.Fusion was achieved, so a revision surgery was completed on (b)(6) 2026 to remove the implants.During the revision surgery, the driver tip fractured when loosening the right l2 locking cap.Due to the inability to replicate surgical conditions, the exact cause of the failure cannot be determined.The overall risk of the system has been maintained and there is no further investigation required.
Event or Problem Description
It was reported on (b)(6) 2025 the patient underwent a spinal procedure to fix l2/3/4 using creo.On (b)(6) 2026, the bone fusion was complete, so the removal surgery was performed.Intraoperatively, when the surgeon attempted to loosen a locking cap at right l2, the tip of driver fractured.The surgeon commented that some fragments may remain inside the patient body.

• Brand Name: CREO
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: 24380507
• Report Number: 3004142400-2026-00027
• Device Sequence Number: 16022196
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6067.0050
• Device Lot Number: ADA017BE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown