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

Model Number	6067.0055
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a spinal procedure using creo.Patient received a revision surgery due to loosening creo screwat th12.When the surgeon attempted to loosen the locking cap on th12 using the driver, the driver tip broke.The broken tip was removed along with the locking cap and creo screw.The surgeon inserted new screws into th12 and th11.The final fixation area was th11/s.It was reported.
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of broken driver tip inspection of the instrument could not be completed as the driver was not returned.Original spinal fusion from t12 to sacrum was completed on the patient and a revision was completed on (b)(6) 2025 to address a loose locking cap at t12.It was confirmed the tip was removed from the patient and fractured driver was returned and confirmed the reported issue.The observed risk level was within the expected risk level.

• 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: 24307472
• Report Number: 3004142400-2026-00015
• Device Sequence Number: 9678616
• Product Code: LXH
• UDI-Device Identifier: 00889095167955
• UDI-Public: 00889095167955
• 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: 2025
• 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): 02/10/2026

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: 6067.0055
• Device Lot Number: BTW259ED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/10/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female