microTargeting™ Platform MP-KIT-P-BI-00590Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00873263005903), received between Aug 23, 2019 and Nov 1, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  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.

  Patient problems: Movement Disorder

  MAUDE report 20588370 ↗
• InjuryAug 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Movement Disorder

  MAUDE report 17548901 ↗
• InjuryJul 13, 2022Image Orientation Incorrect; Malposition of Device

  DURING DEPTH ELECTRODE (MER) PLACEMENT, MER WAS NOT CONCLUSIVE ON THE FIRST PASS AND THE MICROELECTRODE WAS FOUND IN IMAGING (IN BRAINLAB) TO BE ROUGHLY 2MM ANTERIOR AND 3MM LATERAL FROM ITS EXPECTED LOCATION. IMAGE REGISTRATION WAS DIFFICULT DUE TO THE O-ARM SPIN SCAN BEING FLIPPED TOP TO BOTTOM. PHYSICIAN WAS ABLE TO COMPLETE THE REGISTRATION AND DETERMINED AN OFFSET MOVE TO TARGET. WHILE I WAS ATTEMPTING TO REGISTER THE O-ARM SCAN IN NAVIGATOR, HE HAD REMOVED THE DRIVE, POSITIONER AND HUB TO BEGIN SETUP FOR THE SECOND PASS. EQUIPMENT SETUP WAS CHECKED. MER WAS ALSO NOT CONCLUSIVE ON THE SECOND PASS. THE SECOND PASS O-ARM SCAN SHOWED THE MICROELECTRODE ON THE OPPOSITE SIDE OF TARGET FROM THE FIRST PASS. THE DOCTORS CONFERRED AND CONCLUDED THE INITIAL CENTER TRACK SHOULD HAVE PLACED THEM AT TARGET AND DECIDED TO TRY THAT AGAIN, WITH AN ELECTRODE ALSO IN THE POSTERIOR TRACK TO ADD ADDITIONAL MER DATA, HOPING TO NOT NEED A FOURTH PASS. MER ON BOTH CENTER AND POSTERIOR TRACKS OF THE THIRD PASS WAS GOOD ENOUGH FOR THE DOCTORS TO PLACE A LEAD IN THE POSTERIOR TRACK. AN O-ARM SPIN WAS NOT DONE, AS POST OP CT HAD BEEN SCHEDULED AND THEY DIDN'T WANT TO EXPOSE THE PATIENT TO EXCESSIVE RADI

  Patient problems: Ambulation or Postural Difficulties; Confusion/ Disorientation; Dysphasia; Failure of Implant; Muscle Weakness/Atrophy

  MAUDE report 15005678 ↗
• InjuryNov 16, 2021Malposition of Device; Positioning Problem; Appropriate Device Problem Term/Code Not Available; Positioning Problem

  AFTER DBS BILATERAL LEAD PLACEMENT SURGERY USING STARFIX BILATERAL PLATFORM, IT WAS NOTED THAT THE POST OP CT REVEALED THAT ON THE LEFT SIDE THE LEAD WAS PLACED APPROPRIATELY, HOWEVER THE RIGHT SIDE REVEALED IN POST OP SCANS THAT THE LEAD WAS 2.8 CM DEEPER THAN EXPECTED. THIS DID NOT CAUSE A DELAY IN DBS SURGERY, WHEN THE LEAD WAS PLACED. NO HARM TO THE PATIENT WAS CAUSED DURING THE SURGERY. A REVISION SURGERY WAS COMPLETED THE FOLLOWING DAY AND RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821534 ↗
• MalfunctionJun 29, 2021Use of Device Problem; Use of Device Problem; Output Problem

  INCIDENT OCCURRED ON (B)(6) 2021, DURING A BILATERAL PLATFORM CASE USING FHC WAYPOINT STEREOTACTIC PLATFORM (MP-KIT-P-BI). WHILE FITTING THE PLATFORM TO THE PATIENT, IT DID NOT FIT. THE CASE HAD TO BE CANCELLED AND RESCHEDULED FOR (B)(6) 2021. AFTER THE CASE WAS CANCELED, NEW SCANS WERE COMPLETE AND THE PLATFORM WAS REBUILT USING THE NEW SCANS. THE FOLLOW UP CASE WAS COMPLETED ON (B)(6) 2021 SUCCESSFULLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089004 ↗
• MalfunctionOct 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756025 ↗
• MalfunctionAug 23, 2019Material Deformation; Material Deformation

  PHYSICIAN HAD DIFFICULTY ATTACHING THE STARFIX PLATFORM TO THE IMPLANTED FIDUCIALS AT THE START OF THE CASE. HE CHECKED MULTIPLE TIMES THE PEEK STANDOFFS FROM THE SKS KITS AND WAS STILL HAVING DIFFICULTY ATTACHING THE FINAL POSTERIOR LEFT FOOT THE STANDOFF. IT SHOWED A 3MM POSTERIOR SHIFT THAT PHYSICIAN DID NOT FEEL COMFORTABLE PROCEEDING WITH THE SURGERY WITH 3 LEGS WITHOUT KNOWING WHY THE 4TH LEG WAS SHIFTED SO MUCH. THE SURGERY WAS CANCELLED AND THE IMPACT TO THE PATIENT WAS OPENING THE FIDUCIAL SITES AND CLOSING AGAIN AND HAVING THE PATIENT GET ANOTHER CT TO DOUBLE CHECK EVERYTHING. THE CASE CONCLUDED SUCCESSFULLY WITH THE USE OF THE PLATFORM CREATED FROM THE 2ND SET OF CT SCANS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927503 ↗