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

Model Number	1172.2021S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon, dr.(b)(6), was attempting to place bilateral cages into a single disc space.He placed and opened the first cage successfully.When he impacted the second cage into the disc space, it appeared that he may have made contact with the first cage that was already implanted.He stopped to take an x-ray and was able to confirm that he had made contact with the first cage and it had migrated anteriorly past the anterior border of the disc space.He then pulled the second cage out and attempted to retrieve the first cage.After multiple attempts to engage the first cage with the inserter and hospital instruments he landed up inadvertently moving the cage outside of the disc space.He proceeded with the procedure and placed a unilateral cage at that level.
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 implant in question was not returned for evaluation and there were no images provided.Additionally, attempts to get more information were unsuccessful.In the reported information, it was confirmed that the first sable cage deployed during the bilateral plif procedure was contacted by the second cage, causing the first cage to migrate past the anterior border of the disc space.It is possible that the implant migration was caused by user error in positioning of either the first or second implant.However, without further information, the exact cause could not be established.While the status of the patient is unknown, the worst-case risk level effect was evaluated.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, b5, d2, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that the surgeon was attempting to place bilateral cages into a single disc space.He placed and opened the first cage successfully.When he impacted the second cage into the disc space, it appeared that he may have made contact with the first cage that was already implanted.He stopped to take an x-ray and was able to confirm that he had made contact with the first cage and it had migrated anteriorly past the anterior border of the disc space.He then pulled the second cage out and attempted to retrieve the first cage.After multiple attempts to engage the first cage with the inserter and hospital instruments he landed up inadvertently moving the cage outside of the disc space.He proceeded with the procedure and placed a unilateral cage at that level.

• Brand Name: SABLE
• 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: 23360336
• Report Number: 3004142400-2025-00231
• Device Sequence Number: 13002964
• Product Code: MAX
• UDI-Device Identifier: 00889095965889
• UDI-Public: 00889095965889
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192115
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 1172.2021S
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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 Sex: Unknown