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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the instrument was broken.The surgeon hammered anchor over the impactor to the hard bone, it resulted stretching and the tip of threaded rod was broken.Its tip was still struck in coalition implant.The implant is still in patient and the broken piece is threaded in the hold of the coalition.
Additional Manufacturer Narrative
No part was returned for evaluation.It was reported that, while the surgeon was impacting a coalition mis anchor into hard bone, the threaded rod broke.The case was completed, and the tip of the broken threaded rod was left in the spacer.This evaluation determined that the failure was within the expected risk; therefore, no further actions will be taken at this time.No determinations could be made as to the cause of the reported issue.

• 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: 25669130
• Report Number: 3004142400-2026-00134
• Device Sequence Number: 13373723
• Product Code: LXH
• UDI-Device Identifier: 00889095305395
• UDI-Public: 00889095305395
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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
• Device Lot Number: JNB118CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 74 KG