MAUDE Adverse Event Report: Integra NeuroSciences Implants S.A. Kit containing CC1.P1 and the IP2 introducer; Licox

Catalog Number	IP2P
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that a patient was scheduled for a ct scan, and it was noted that the licox bolt in the complete brain imc probe kit (im3steu) appeared "loose." new frank red blood was coming from the licox which appeared to be leaning forward and partially dislodged.The staff in the room did not witness a "specific event/ action" that caused licox to dislodge.The staff cleansed the site with sterile saline and gauze, and the patient's vital signs remained stable per trend.Neurosurgery then attended at bedside to remove the licox, and another monitor was inserted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The im3steu complete brain imc probe kit was not returned after three good faith effort (gfe) attempts were made; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The definite root cause could not be determined; however, the probable root cause for the reported complaint could be linked to the product or could be due to human misuse.If the sample is returned, this complaint will be re-opened, and the device evaluated.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: Kit containing CC1.P1 and the IP2 introducer
• Common Device Name: Licox
• Manufacturer (Section D): Integra NeuroSciences Implants S.A.; 2905 route des dolines; 2905 route des dolines; sophia antipolis
• Manufacturer (Section G): Integra NeuroSciences Implants S.A.; 2905 route des dolines; sophia antipolis
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 22984213
• Report Number: 3013886523-2025-00240
• Device Sequence Number: 15683029
• Product Code: GWM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: IP2P
• Device Lot Number: 7495431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 09/03/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/31/2025; 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown