MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION MIS; COALITION MIS ANCHOR, 12MM

Model Number	1136.2011
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coalition mis anchor has migrated post operatively.This event occurred in switzerland.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.The imaging provided shows the inferior anchor of the spacer had backed out.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.The imaging provided shows the inferior anchor of the spacer had backed out.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a coalition mis anchor has migrated post operatively.This event occurred in switzerland.

• Brand Name: COALITION MIS
• Common Device Name: COALITION MIS ANCHOR, 12MM
• 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: 18837792
• Report Number: 3004142400-2023-00125
• Device Sequence Number: 18025752
• Product Code: ODP
• UDI-Device Identifier: 00889095389999
• UDI-Public: 00889095389999
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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
• Device Lot Number: GBB084FB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 60 KG