MAUDE Adverse Event Report: FHC, INC. MICROTARGETINGTM PLATFORM

Model Number	MP-KIT-P-EO
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fhc is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by fhc, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Fhc has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, fhc, or its employees that the device, fhc or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Fhc objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
A complaint was received on (b)(6) 2026, for a multi oblique epilepsy platform (mp-kit-p-eo, sn (b)(6) used on (b)(6) 2026.The reporting physician identified a discrepancy between the depth embossed on the platform (177 mm) and the correct depth provided in the planning documentation (117 mm).The discrepancy was recognized prior to use, preventing potential misplacement of the lead.Investigation determined that the correct depth was present in the planning software outputs and manufacturing documentation.The discrepancy was introduced during manual transcription of depth values onto the platform.Device history records showed all required inspections and release steps were completed; however, the incorrect value was not identified.

• Brand Name: MICROTARGETINGTM PLATFORM
• Common Device Name: PLATFORM
• Manufacturer (Section D): FHC, INC.; 1201 main st.; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC.; 1201 main st.; bowdoin ME 04287
• Manufacturer Contact: kelly moeykens ; 1201 main st.; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 25315475
• Report Number: 3002250546-2026-00003
• Device Sequence Number: 17456582
• Product Code: HAW
• UDI-Device Identifier: 00873263005965
• UDI-Public: 00873263005965
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K092192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MP-KIT-P-EO
• Device Catalogue Number: MP-KIT-P-EO
• 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: 05/04/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown