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

Model Number	1124.1011S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the original case on (b)(6) 2024 the surgeon noticed the altera cage has collapsed on a follow up on (b)(6) 2025.The implant remains in the patient.This event occurred in the uk.
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
It was reported that a 10x26mm, 8-12mm, 8° altera spacer was found collapsed during a post-operative evaluation of the patient.The spacer was implanted on (b)(6) 2024, and the post-operative evaluation took place on (b)(6) 2025.The clinical representative present during the case was contacted via email on 20 feb 2026, 24 feb 2026, 26 feb 2026, and 6 mar 2026 but was unable to provide imaging, operative notes, or description of the patient's current condition.Therefore, it could not be confirmed that the spacer collapsed as reported and the complaint is invalid.Upon review of historical complaint trends of the altera spacer family, no confirmed complaints of post-operative collapse were reported.The following sections were updated for this supplemental report: b4, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that after the original case on (b)(6) 2024 the surgeon noticed the altera cage has collapsed on a follow up on (b)(6) 2025.The implant remains in the patient.This event occurred in the uk.

• Brand Name: ALTERA
• 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: 24251343
• Report Number: 3004142400-2026-00020
• Device Sequence Number: 8309634
• Product Code: MAX
• UDI-Device Identifier: 00889095258356
• UDI-Public: 00889095258356
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1124.1011S
• Device Lot Number: GBC396BD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown