MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L P BOLT; ICP MICRSOSENSORS - CERELINK

Catalog Number	826852
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported the plastic bolt of a cerelink microsensor (id (b)(6)) is no longer fitting into the hole created by the drill bit.The drill bill that was used did not create the appropriate sized hole in the patient¿s skull for the bolt to fit.The bolt was too unstable to hold the catheter and therefore the catheter had to be tunneled under the skin.The drill bit used was a codman product.The patient passed away; however, it was confirmed by the customer that the patient's death was not related to the device.The cause of death was documented as "traumatic brian injury".
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
N/a.
Additional Manufacturer Narrative
Additional information received: the drill used was a medtronic hand drill (the codman hand drill has been in backorder), with an adult bolt and a 5.8mm drill bit.Surgeon technique was according to policy.Date of death: (b)(6) 2024.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h1, h2, h3, h6, h11.The cerelink microsensor (id 826852) was returned for evaluation.Failure analysis - the issue of the complaint was not confirmed as all measurements made on the returned product were within the specifications: - drill bit (#(b)(4)): 5.8 mm diameter.- skull bolt adult (#(b)(4)): 0.25 inch diameter.- skull bolt pediatric (#(b)(4)): 0.25 inch diameter.Root cause analysis - no formal cause could be determined as the complaint was not confirmed.The possible root cause could be due error during the product utilization.A medical assessment was requested to integra's medical safety department and the following was provided: ¿a causal relationship between the device and the reported event of ¿bolt did not and drill bit did not fit¿ is not related to device as it appears to have been procedurally related.The patient¿s demise was related to traumatic brain injury.".

• Brand Name: CERELINK ICP PROBE 1L P BOLT
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21483318
• Report Number: 3013886523-2025-00045
• Device Sequence Number: 15556925
• Product Code: GWM
• UDI-Device Identifier: 10381780520696
• UDI-Public: 10381780520696
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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 Catalogue Number: 826852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 09/02/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/04/2025; 09/19/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male