MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ PLATFORM; BILATERAL PLATFORM, PATIENT SPECIFIC

Model Number	MP-KIT-P-BI-00590
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician called fhc while setting up for their surgery on 9/24, questioning the product embossing.The physician remembered that he designed his platform with a height of 120mm with the embossed text on the product reading "t=30", the product he received was embossed with "t=40".While on the phone with the physician, the fhc technician reviewed the production file zip within the.3da file was 120mm and specified an embossing text of "t=30" and confirmed to the physician that the product had incorrect embossing.The physician was understanding of this, and proceeded with the operation without issue.There was no harm to the patient.
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.

• Brand Name: MICROTARGETING¿ PLATFORM
• Common Device Name: BILATERAL PLATFORM, PATIENT SPECIFIC
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: kelly moeykens ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 20588370
• Report Number: 3002250546-2024-00004
• Device Sequence Number: 6568243
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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-BI-00590
• Device Catalogue Number: MP-KIT-P-BI
• Device Lot Number: N/A
• 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: 09/24/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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