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

Catalog Number	826638
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
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 physician reported a microsensor (id 826638) was implanted due to external trauma on an unknown date.The physician did not make enough incision in dura mater and implanted the device, therefore, the patient developed epidural hematoma after the device was implanted.According to information provided, it is unknown if the sensor failed.It is also unknown if the sensor was explanted due to this issue.It is unknown how the epidural hematoma was treated.It is also unknown if the trauma was the cause of the epidural hematoma.The current status of the patient is unknown.
Additional Manufacturer Narrative
The microsensor (id 826638) was not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined, however, the probable root cause for the reported complaint could be due to drill geometry.According to the description of the issue, the root cause could be also due to the fact that the surgeon didn't make enough incision in dura mater.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Common Device Name: ICP MICROSENSORS
• 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: 19538711
• Report Number: 3013886523-2024-00171
• Device Sequence Number: 8412551
• Product Code: GWM
• UDI-Device Identifier: 10381780520504
• UDI-Public: 10381780520504
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown