MAUDE Adverse Event Report: FHC, INC. WAYPOINT STEREOTACTIC PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	MP-KIT-P-BI
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
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
On (b)(6) 2023, the physician reported that mp-kit-p-bi platform sn 50504 trajectory was off by couple millimeters in the anterior direction for both sides.The doctor confirmed with mer and post-op ct.The doctor also confirmed the platform, and screws were well seated.The case was completed, and the doctor did not report impact to the patient.Fhc reviewed the plans and associated product documentation and did not find any errors that would correlate to this issue.On (b)(6) 2023 the physician reported to fhc that the dbs lead was placed inaccurately on (b)(6) with platform and was not working well and he would performing revision surgery to reposition the lead.

• Brand Name: WAYPOINT STEREOTACTIC PLATFORM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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 ; 2076665651
• MDR Report Key: 17548901
• Report Number: 3002250546-2023-00002
• Device Sequence Number: 20504087
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 Model Number: MP-KIT-P-BI
• Device Lot Number: 2401
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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: Hospitalization
• Patient Sex: Unknown