MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CORRIDOR FIXATION SYSTEM; 1.05MM K-WIRE X 600MM, TAPERED TIP, NITINOL

Model Number	648.007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a case the tip of the k-wire broke off and was retained in the patient post operatively.This event occurred in austria.
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.The tip of the k-wire remained in the patient post-operatively.The fracture occurred during the treatment of a type 2 dens fracture.After insertion of the soft tissue retractor (648.101) and the k-wire guiding cannula screw guide (648.010s), the surgeon inserted the 1.05mm k-wire x 600mm, tapered tip, nitinol (648.007).The tip of the k-wire fractured after being inserted roughly 5mm into c2, and the tip could not be retrieved from the patient.This evaluation determined that this event was within expected risk; therefore, no further actions will be taken at this time.The following sections have been updated for this supplemental report: b4, g6, h2, h3, h6, h10.
Event or Problem Description
It was reported that during a case the tip of the k-wire broke off and was retained in the patient post operatively.This event occurred in austria.

• Brand Name: CORRIDOR FIXATION SYSTEM
• Common Device Name: 1.05MM K-WIRE X 600MM, TAPERED TIP, NITINOL
• 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: 22179044
• Report Number: 3004142400-2025-00131
• Device Sequence Number: 9739198
• Product Code: LXH
• UDI-Device Identifier: 00849044034301
• UDI-Public: 00849044034301
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D368745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 07/10/2025

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: 648.007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female