MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION MIS; THREADED ROD

Model Number	6136.1002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case, an coalition mis threaded rod broke at the tip which remains in the patient post operatively.This event occurred in the united kingdom.
Additional Manufacturer Narrative
The device was unavailable for evaluation as it remains in the patient.It was reported that a coalition mis threaded rod broke at the tip and the tip remains in the patient post-operatively.This event occurred on (b)(6) 2024 in the united kingdom.It was explained that during a case, while disengaging the double barrel guide from the implant, the tip of the threaded rod broke and stayed inside the patient.It was stated that the tip of the threaded rod was "buried in the implant" and that the surgeon decided it would be better to leave the tip in the implant than to try to remove the implant.Images of the threaded rod were provided and showed there was a fracture at the distal tip.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a case, an coalition mis threaded rod broke at the tip which remains in the patient post operatively.This event occurred in the united kingdom.
Additional Manufacturer Narrative
The device was available for evaluation.Visual inspection showed that the threads at the distal tip were fractured off.Because the exact cause of fracture is unknown, no determinations could be made as to the cause of the reported issue.

• Brand Name: COALITION MIS
• Common Device Name: THREADED ROD
• 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: 19035885
• Report Number: 3004142400-2024-00068
• Device Sequence Number: 12597338
• Product Code: LXH
• UDI-Device Identifier: 00889095305395
• UDI-Public: 00889095305395
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 6136.1002
• Device Lot Number: JNU097BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2017
• 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