MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION

Model Number	1134.0100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.It was reported that the left side l3 creo mis tulip on a l3-l4 construct had disassociated from the screw shank.The initial posterior fixation surgery was performed 2 months prior to revision case on (b)(6) 2025.Reviewing the dhr's, the implant were stated to be made from the correct materials.According to the sales rep, the patient with no post-op pain came in for a routine visit where it was discovered that the l3 screw had disassociated with the screw shank.Upon observation of the returned creo mis tulip, the inner one-piece clamp was observed to have only one side of the clamp flush with the bottom of the tulip and the other side in a slight angle.This could suggest that the rod may not have been evenly lock down during final tightening.Since the modular screw shank that dissociated from the creo mis tulip was not returned, we cannot determine the exact cause of the reported issue with the available information.
Event or Problem Description
It was reported that screw using, patient had surgery 2 months ago and returned with left side hardware loose.L3 tulip was not attracted to screw shank.

• Brand Name: CREO
• Common Device Name: CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION
• 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: 22689822
• Report Number: 3004142400-2025-00157
• Device Sequence Number: 8268488
• Product Code: MNH
• UDI-Device Identifier: 00889095071146
• UDI-Public: 00889095071146
• 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
• 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): 08/01/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1134.0100
• Device Lot Number: BAC403UH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown