MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION MIS; ORTHOPAEDIC INORGANIC IMPLANT INSERTER/EXTRACTOR, REUSABLE

Model Number	6136.2020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No part was returned for evaluation and 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.
Event or Problem Description
It was reported that one of the stoppers of the implant inserter snapped off.The implant inserter stopper, one of them snapped off after inserting the implant, the surgeon noticed it, and he looked for it around the operative site, but he can't find it, and he did an x-ray on the patient and nothing can be found on the patient.
Additional Manufacturer Narrative
No part was returned for evaluation and 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.Further information was able to be received on 18 dec 2025, the part was a custom freehand inserter.The instrument fractured before the case, but the surgeon noticed during the case and was concerned.As previously reported, there was nothing left in the patient.The following sections were updated for this supplemental report: b4, e1, g3, g6, h2, h10.
Event or Problem Description
It was reported that one of the stoppers of the implant inserter snapped off.The implant inserter stopper, one of them snapped off after inserting the implant, the surgeon noticed it, and he looked for it around the operative site, but he can't find it, and he did an x-ray on the patient and nothing can be found on the patient.

• Brand Name: COALITION MIS
• Common Device Name: ORTHOPAEDIC INORGANIC IMPLANT INSERTER/EXTRACTOR, 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: 23827219
• Report Number: 3004142400-2025-00298
• Device Sequence Number: 13000532
• Product Code: LXH
• UDI-Device Identifier: 00889095306194
• UDI-Public: 00889095306194
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 6136.2020
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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 Sex: Unknown