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

Model Number	6120.2010
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Multiple Organ Dysfunction Syndrome (3261)
Date of Event	12/02/2025
Type of Reportable Event	Death
Event or Problem Description
T was reported that these parts would engage with tulip, but the set screw would not thread into the tulip.When the reducers were on the tulip & fully reduced rod.This added an extra 45 min to surgery as they troubleshooted the issues, ultimately resolved by switching to new instrumentation.The patient passed away at the hospital 5 days later, the surgeon believes the patient had proposal infusion syndrome.
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of: death.The part was not returned so it is not possible to verify the reported issue.The reported malfunction of the geared reducer, threaded during surgery.The reducer engaged with the tulip, but the set screw failed to thread into the tulip.No new information uncovered; confirmed issue was resolved and construct was locked down.Passed away 5 days post-surgery: cause currently unknown.Matches system risk analysis hazard: instrument binds when reducing.Observed risk level aligns with expected risk level.Overall system risk remains maintained and there is no further investigation required.

• 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: 23975742
• Report Number: 3004142400-2026-00005
• Device Sequence Number: 16131686
• Product Code: LXH
• UDI-Device Identifier: 00889095173376
• UDI-Public: 00889095173376
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/06/2026

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: 6120.2010
• Device Lot Number: DIV102AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/06/2026
• 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: Death; Other
• Patient Age: 48 YR
• Patient Sex: Unknown