MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION; 3.6MM BONE SCREW, VARIABLE, SELF-TAPPING, 14MM

Model Number	184.114
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 3.6mm bone screw, variable, selftapping, 14mm (184.114) was returned for evaluation.Visual inspection of the bone screw reveals minor wear from intra-operative usage.Per requirements on the inspection sheet 184114ins (rev.H), the bone screw passes all dimensional and functional specifications; signaling no inherent issue dimensionally or functionally.Standard distraction and trialing was performed during the procedure.An awl and drill were used to prepare each bone screw hole, drill sizing and depth is unknown.No tapping was performed.It was stated that the set screw positioner, 2.0mm hex, torque limiting (650.312) was audibly and tactically felt to torque out, however it was not visual confirmed if the set screw on the spacer was fully blocking the bone screws.It was also noted the patient had poor bone quality, and there was no reports of post-operative fall or injury.This evaluation determined that this failure was within expected risk, which is low.Therefore, no further actions will be taken at this time.
Event or Problem Description
It was reported that a revision was needed due to a coalition screw having backed out.This event occurred in japan.

• Brand Name: COALITION
• Common Device Name: 3.6MM BONE SCREW, VARIABLE, SELF-TAPPING, 14MM
• 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: 22926670
• Report Number: 3004142400-2025-00180
• Device Sequence Number: 9079598
• Product Code: ODP
• UDI-Device Identifier: 00849044007626
• UDI-Public: 00849044007626
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 184.114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 77 YR
• Patient Sex: Male
• Patient Race: Asian