MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION MIS; LAPAROSCOPIC ACCESS CANNULA, REUSABLE

Model Number	6136.1002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No part was returned for evaluation.The sales rep was contacted and shared that the threaded rod broke while the spacer was being impacted into the disc space.The surgeon impacted the spacer further using a tamp and fixated the spacer with screws.The case was completed.The tip of the broken threaded rod was left flush in the spacer.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.
Event or Problem Description
It was reported that during surgery the threads broke off the threaded rod.When the surgeon started impacting the driver to place the spacer, the threads snapped off.The surgeon finished placing the implant using a tamp and the surgery was completed.

• Brand Name: COALITION MIS
• Common Device Name: LAPAROSCOPIC ACCESS CANNULA, REUSABLE
• 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: 24737405
• Report Number: 3004142400-2026-00061
• Device Sequence Number: 9214316
• Product Code: LXH
• UDI-Device Identifier: 00889095305395
• UDI-Public: 00889095305395
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/30/2026

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: 6136.1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White