MAUDE Adverse Event Report: FHC, INC. FHC WAYPOINT STEREOTACTIC SYSTEM; STEREOTACTIC INSTRUMENT

Model Number MP-KIT-P-BI-00590

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

Physician informed fhc that there was an issue with a starfix case.Physician reports that a platform height of 130 was chosen for the plan for this bilateral platform for patient.In the case physician observed a value of t=30 on the platform embossing.Being new to starfix, she followed this label and implanted the lead at 30 without questioning it.In post-operative scans, it was observed that the lead is 10 mm short of her target.The patient impact is that he/she will require a revision which bick plans to do using rosa.Physician informed fhc that they decided to bring the patient back in for a revision on10/1 with the same platform.They re-processed the platform and reattached without issue.Patient did very well during the revision surgery and in post-op.

• Brand Name: FHC WAYPOINT STEREOTACTIC SYSTEM
• Type of Device: STEREOTACTIC 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 04287 ; 2076665651
• MDR Report Key: 10756025
• MDR Text Key: 213702150
• Report Number: 3002250546-2020-00006
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MP-KIT-P-BI-00590
• Device Catalogue Number: MP-KIT-P-BI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization