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

Model Number	1136.2011
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that both anchors backed out after the surgery.The anchors were removed and an xtend plat was placed over the coalition mis ti spacer.The anchors were removed after the case.
Additional Manufacturer Narrative
The part was not returned for evaluation.The purpose of this rationale is to determine the risk associated with "migration/displacement of screw/anchor".Associated with "migration/displacement of screw/anchor".The sales rep was contacted and shared two lateral x-ray images that showed a coalition mis anchor migrated anteriorly and was not blocked by the spacer's set screw.The x-rays were taken at a post-op follow-up appointment.A revision surgery was scheduled to address the backout, and the rep shared that during the revision surgery, after the surgeon dissected through the tissue to visualize the spacer, the surgeon noted the blocking set screw of the spacer was in the unlocked position.It is unclear whether the set screw was locked during the original surgery or if it became unlocked afterwards.No additional information was available.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.The following sections were updated for this supplemental report.B4, b7, g6, h2, h6, h10.
Event or Problem Description
It was reported that both anchors backed out after the surgery.The anchors were removed and an xtend plat was placed over the coalition mis ti spacer.The anchors were removed after the case.

• Brand Name: COALITION
• 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: 23407576
• Report Number: 3004142400-2025-00265
• Device Sequence Number: 9076051
• Product Code: ODP
• UDI-Device Identifier: 00889095389999
• UDI-Public: 00889095389999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173115
• 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): 11/20/2025

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: 1136.2011
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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