N/A 803361Recalls & reported problems
inomed Medizintechnik GmbH · Opti pin fixing pin 30 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 04250307606184), received between Dec 17, 2025 and Dec 17, 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
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 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 HAD SECURED THE HEADRING WITH OPTIPINS TO THE PATIENT'S HEAD. THE REPRESENTATIVE NOTICED THAT THE FRONT LEFT PIN APPEARED TO BE FLEXED AND INFORMED THIS ISSUE TO THE SURGEON, AND RECOMMENDED THAT THEY ADJUST THE PIN AND RING IN ORDER FOR THE OPTIPIN TO BE MORE ORTHOGONAL TO THE BONE FOR OPTIMAL FIXATION OF THE FRAME. WHEN THE SURGEON WAS REMOVING THE OPTIPIN USING THE TORQUE WRENCH, THE PIN SNAPPED . AND THIS ABRUPT SNAPPING ALSO CONTRIBUTED TO THE FRONT PIN ON THE RIGHT SNAPPING ALMOST IN THE SAME MOMENT. THIS ALSO LEADING TO SLIPPING OF THE PATIENT HEAD AND CAUSED THE THE SKIN AT THE BACK OF THE PATIENS HEAD TO BE LACERATED. A 15-MINUTE DELAY WAS NOTED.
Patient problems: Laceration(s)
MAUDE report 23825740 ↗
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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.
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