MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICROSENSOR KIT W/ SKULL BOLT; ICP

Catalog Number	826638
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a microsensor (id (b)(6)) was working properly in the morning of (b)(6) 2026.It was disconnected to perform computed tomography (ct) scan and magnetic resonance imaging (mri).When reconnecting the device, ¿connect transducer¿ message was displayed and did not detect the sensor.On (b)(6) 2026, it was confirmed that another sensor was detected by the main device so it is unlikely that the issue was caused due to cable disconnection.The sensor was removed due to failure.According to the information provided, the monitor and the cable used with the microsensor were unknown.No adverse consequences to the patient were observed and no information on surgical delay.
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
Na.
Additional Manufacturer Narrative
The microsensor (id (b)(6)) was returned for evaluation.Device history review: the product code 826638 with lot 7508824 sn (b)(6), conformed to the specifications when released to stock.Failure analysis: the sensor diaphragm is broken.The catheter has different kinks located at 7.5 cm, 8.9 cm, 13.9 cm, 14.2 cm, 21.9 cm and 25.5 cm from the distal tip.No further testing.The complaint was confirmed.Root cause analysis: the possible root cause for this issue reported by the customer could be due to mishandling of the device.

• Brand Name: MICROSENSOR KIT W/ SKULL 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: 24711886
• Report Number: 3013886523-2026-00068
• Device Sequence Number: 17574468
• Product Code: GWM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 826638
• Device Lot Number: 7508824
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown