N/A 803363Recalls & reported problems
inomed Medizintechnik GmbH · Opti pin fixing pin 50 mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250307606207), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING THE PROCEDURE PREPARATION FOR A SEEG SURGERY, THE SURGEON, RESIDENT AND PA WERE PUTTING THE FRAME ON THE PATIENT. THEY FIT THE FRAME ON THE PATIENT AND MADE ADJUSTMENTS TO THE FRONT TWO POSTS TO PIN ORTHOGONAL TO THE PATIENTS HEAD. 50MM PINS WERE PICKED OUT FOR THE FRONT POSTS AND 60MM PINS WERE PICKED OUT FOR THE BACK. THE PA AND RESIDENT STARTED TO SCREW THE PINS INTO THE SKULL. THE PA BEGAN TO TIGHTEN THE FRONT RIGHT PIN WITH THE SOCKET WRENCH AFTER THE OTHER THREE PINS HAD BEEN HAND TIGHTENED WHEN THE FRONT RIGHT PIN BROKE. A NEW PIN WAS USED. ALL FOUR SCREWS WERE TAKEN OUT AND THE FRAME WAS MOVED HIGHER UP ON THE PATIENTS HEAD TO ENSURE THE FIDUCIAL POSTS WOULD BE IN THE O-ARM FIELD OF VIEW. THE PINS WERE SCREWED BACK INTO THE PATIENT'S HEAD. AFTER GETTING THEM ALL STARTED IN THE POSTS, THE TORQUE WRENCH WAS USED TO TIGHTEN THEM. A O-ARM WAS TAKEN AND WHILE REVIEWING THE PIN LOCATIONS, IT WAS NOTED THE FRONT LEFT PIN HAD PUNCTURED THROUGH THE SINUS. THE OTHER THREE PINS WERE OKAY. THE SURGEON DECIDED TO CONTINUE ON AND CONTACTED ENT ABOUT STEPS AFTER THE SURGERY. THERE WAS ALSO ANOTHER SMALL PUNCTURE NOTED AT THE ORIGINAL PIN LOCATION BEFORE THE RIG
Patient problems: Needle Stick/Puncture
MAUDE report 22769059 ↗
Other Neurological Stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page