MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XPAND; VERTEBRAL BODY PROSTHESIS

Model Number	116.109
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025, the original surgery was performed.The pre-operative measurement showed a height of approximately 27 mm, so a 26 mm xpand was selected.The post-implantation x-ray confirmed that both the depth and height were appropriate, and the spikes were well seated against the superior and inferior endplates.However, about one month later, subsidence was observed, so the implant was removed and replaced with another brand of cage.There was no impact to the patient.The rep was able to provide further detail and stated "no" when asked if the surgical technique for xpand was utilized.They said the lock was not secured properly and due to the angle of insertion the surgeon was unable to get tactile feedback to confirm whether it was locked.The part has not been returned.The dhr was pulled and shows no discrepancies within the lot number provided.The complaint is indeterminate as the root cause of this malfunction cannot be determined from the given information.A risk reconciliation was performed and confirms that the type and frequency of this failure is captured in our latest risk analysis.
Event or Problem Description
It was reported that on (b)(6) 2025, the original surgery was performed.The pre-operative measurement showed a height of approximately 27 mm, so a 26 mm xpand was selected.The post-implantation x-ray confirmed that both the depth and height were appropriate, and the spikes were well seated against the superior and inferior endplates.However, about one month later, subsidence was observed, so the implant was removed and replaced with another brand of cage.

• Brand Name: XPAND
• Common Device Name: VERTEBRAL BODY PROSTHESIS
• 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: 23936036
• Report Number: 3004142400-2025-00297
• Device Sequence Number: 13168462
• Product Code: MQP
• UDI-Device Identifier: 00849044022537
• UDI-Public: 00849044022537
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050850
• 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
• Report Date (Section B): 12/31/2025

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: 116.109
• Device Lot Number: BGC331AK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2024
• 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 Sex: Male
• Patient Weight: 80 KG