MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED CAMINO; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Lot Number	118D00926371
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During placement of an intercranial pressure monitoring bolt the neurosurgeon noted that the bolt would not screw into the hole made by the drill.While repositioning it, the bolt broke off inside the patient's head.The neurosurgeon was able to retrieve the piece remaining in the patient with a clamp.The neurosurgeon was then able to place a ventriculostomy.

• Brand Name: CAMINO
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED
• MDR Report Key: 19885316
• Report Number: MW5157892
• Device Sequence Number: 20782802
• Product Code: GWM
• UDI-Device Identifier: 00382830047524
• UDI-Public: (01)00382830047524
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/29/2024

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 Lot Number: 118D00926371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American