MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE-L SPACER, 18X55MM, 10-17MM, 10°

Model Number	193.335
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion of a rise-l spacer the surgeon noticed transudate in the patient.This event occurred in japan.
Additional Manufacturer Narrative
The device was unavailable for evaluation.The procedure was completed, and there were no immediate adverse effects to the patient.No further evaluation can be made given the provided information.The exact reason or cause for the transudate appearing during the case could not be determined, and so the complaint is indeterminate.The investigation will be reopened if further information is provided.

• Brand Name: RISE
• Common Device Name: RISE-L SPACER, 18X55MM, 10-17MM, 10°
• 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: 21893869
• Report Number: 3004142400-2025-00079
• Device Sequence Number: 14313391
• Product Code: MAX
• UDI-Device Identifier: 00889095213966
• UDI-Public: 00889095213966
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 193.335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 04/23/2025
• 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