MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT

Catalog Number	826851
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2025
Type of Reportable Event	Serious 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
A facility reported a cerelink microsensor (id (b)(6)) was implanted on (b)(6) 2025.The device reportedly displayed inaccurate readings that did not correlate with intracranial pressure (icp) values obtained from an accudrain device.During implantation, an incorrect drill bit, rather than the drill bit provided in the bolt kit, was reportedly used, resulting in an incompatible drilled hole and metal bolt.The microsensor was subsequently inserted.The bolt was then removed and reinserted correctly on a second attempt; however, the microsensor was not replaced following removal, despite the device instructions indicating that the microsensor should be replaced after removal.On (b)(6) 2025, following a computed tomography (ct) scan, the receiving neurosurgeon reported elevated icp readings from the microsensor.An external ventricular drain (evd) was placed for comparison and reportedly measured icp values ranging from 8 to 20 mmhg, while the cerelink microsensor reportedly displayed pressures in the 30s to the 50s mmhg.Upon removal of the microsensor, debris was reportedly observed near the tip of the device.The microsensor was removed because the reported readings were considered unreliable.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The cerelink microsensor (id: 826851) was returned for evaluation: failure analysis - received with a damaged serial number label.The icp express = 478; microsensor detected and zeroed without issue.The device passed electronic, noise, and signal drift tests.The complaint was not confirmed.Root cause analysis - the possible root cause for this issue reported by the customer could be ¿unstable sensor performance or incorrect selection of semiconductor components¿.The exact issue reported by customer could not be confirmed as the device worked correctly.As well, the reported issue may result from an incorrect set-up of the device (zeroing).

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• Common Device Name: ICP
• 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: 24034513
• Report Number: 3013886523-2026-00001
• Device Sequence Number: 9058152
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: 10381780520689
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCUDRAIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White