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	Foreign Body In Patient (2687)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a rise was inserted into l4/5.After expanding the rise, the surgeon reviewed the images and noticed space anterior intervertebral.The surgeon then lowered the rise height and inserted it further.Upon re-expanding the rise and reviewing the images, it was found to be over-inserted.The surgeon attempted to correct the position using the inserter, but the rise dislodged from the inserter.Reviewing the images revealed the rise had dropped anteriorly.The patient was transferred to another hospital.The rise was removed from the patient at the hospital on (b)(6) 2025.
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
During a plif procedure on (b)(6) 2025, a rise spacer from lot axc472gg was positioned in l4/l5 and expanded.The surgeon decided to reposition the spacer anteriorly by collapsing the spacer and inserting it further.The spacer was seen to be over-inserted and when attempting to reposition the spacer again the rise decoupled from the inserter and fell anteriorly.The spacer was removed from the patient on (b)(6) 2025.There was negligible harm to the patient.The spacer was not returned for evaluation.However, the corresponding dhr for lot axc472gg was reviewed and there were no material non-conformances, manufacturing errors, or discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Two 8mm inserter forks from lots bju334hc and tix108ac were attached to the event evaluation report.However, only the 8mm inserter fork from lot bju334hc was received for investigation.According to the rep, the 8mm inserter fork from lot tix108ac did not show signs of damage and was returned to normal use.The 8mm inserter fork from lot bju334hc was inspected.All functional and dimensional specifications were conforming, indicating that the inserter fork was not the root cause of the incident.However, one of the four flats on the proximal end of the part showed signs of wear.Because the rise spacer from lot axc472gg was not returned for evaluation, a definitive cause could not be established.However, it is possible that the inserter tube was not tightened onto the inserter fork, which may have resulted in the spacer not being secured when it was being repositioned.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 a rise was inserted into l4/5.After expanding the rise, the surgeon reviewed the images and noticed space anterior intervertebral.The surgeon then lowered the rise height and inserted it further.Upon re-expanding the rise and reviewing the images, it was found to be over-inserted.The surgeon attempted to correct the position using the inserter, but the rise dislodged from the inserter.Reviewing the images revealed the rise had dropped anteriorly.The patient was transferred to another hospital.The rise was removed from the patient at the hospital on (b)(6) 2025.

• 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: 23605382
• Report Number: 3004142400-2025-00276
• Device Sequence Number: 9917690
• 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): 12/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 193.001
• Device Lot Number: AXC472GG
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Male