MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; METALLIC SPINAL INTERBODY FUSION CAGE

Model Number	193.001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that rise implants were inserted at l3/4/5 by plif on (b)(6) 2025.After review of image, the surgeon decided to re-position the rise at right l4/5.The surgeon inserted the inserter into right l4/5 to reposition but accidentally pushed the rise with the inserter, causing it to fall ventrally.A new rise was inserted into right l4/5 and the fixation procedure was completed.On (b)(6) 2025, the rise that had fallen into the ventral space was removed at another hospital.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the risk associated with the identified hazard/failure of implant migration.During a plif procedure on l4/5 on a rise spacer was implanted in the patient and de-coupled from its inserter.While attempting to re-couple the inserter to reposition the implant, the implant was pushed and fell through the anterior disc space.An additional rise spacer was then implanted successfully.No part was provided for this event.The clinical representative was contacted for supporting records, such as imaging taken during the case, but none were available.The representative confirmed that the patient underwent revision surgery the following day (b)(6) 2025) where the incorrectly positioned implant was successfully removed.No patient injury was noted during the revision surgery.Without the part available for evaluation, the exact cause of the event could not be established.The reported failure is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.The following sections were updated for this supplemental report.B4,g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that rise implants were inserted at l3/4/5 by plif on (b)(6) 2025.After review of image, the surgeon decided to re-position the rise at right l4/5.The surgeon inserted the inserter into right l4/5 to reposition but accidentally pushed the rise with the inserter, causing it to fall ventrally.A new rise was inserted into right l4/5 and the fixation procedure was completed.On (b)(6) 2025, the rise that had fallen into the ventral space was removed at another hospital.

• Brand Name: RISE
• Common Device Name: METALLIC SPINAL INTERBODY FUSION CAGE
• 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: 23407579
• Report Number: 3004142400-2025-00270
• Device Sequence Number: 9076053
• Product Code: MAX
• UDI-Device Identifier: 00889095213416
• UDI-Public: 00889095213416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113447
• 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,Followup
• Report Date (Section B): 11/26/2025

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: 193.001
• Device Lot Number: AXC234AG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 75 YR
• Patient Sex: Female