N/A 803365Recalls & reported problems
inomed Medizintechnik GmbH · Opti pin fixing pin 70 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 04250307606221), received between Jun 25, 2025 and Jun 25, 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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A SALES REPRESENTATIVE FROM ZIMMER BIOMET ACCOMPANIED A FIRST-TIME USE OF THE RING AND THE OPTI PINS AT A NEW CUSTOMER IN THE USA. THE OPTI PINS WERE NOT POSITIONED VERTICALLY TO THE SKULL WHEN THE RING WAS POSITIONED ON THE PATIENT'S SKULL, BUT AT AN ANGLE. A TOOL PREVIOUSLY UNKNOWN TO US WAS USED TO TIGHTEN THE OPTI PIN. THE TORQUE SPANNER PROVIDED FOR THIS PURPOSE WAS NOT USED. THIS RESULTED IN PRELIMINARY DAMAGE TO THE OPTI PIN, WHICH WAS RECOGNISABLE BY A CLEAR BENDING OF THE PIN. THE PROCEDURE WAS CONTINUED. A ROSA ROBOT WAS USED TO IMPLANT SEEG ELECTRODES IN THE PATIENT. THE RING WAS USED AS A HOLDING AND REFERENCE SYSTEM FOR THE ROBOT ON THE PATIENT. IN THE COURSE OF THE OPERATION, THE PRE-DAMAGED OPTI PIN BROKE, WHICH LED TO A SLIGHT MOVEMENT OF THE RING AND THUS TO A CHANGE IN THE POSITION OF THE PATIENT IN RELATION TO THE RING. AS A RESULT, THE ROSA ROBOT NO LONGER HAD THE CORRECT TRAJECTORIES IN RELATION TO THE ACTUAL POSITION OF THE PATIENT. THIS LED TO DEVIATIONS FROM THE PLANNED TRAJECTORIES AND THUS TO INCORRECTLY POSITIONED SEEG ELECTRODES. THE PATIENT'S POSTOPERATIVE CONDITION DOES NOT SUGGEST ANY HEALTH IMPAIRMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332035 ↗
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