NA 6000-011-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · LARGE POINTER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker LARGE POINTER is part of a neurological stereotaxic instrument set used to position needles and instruments during brain surgery. The 49 reports mostly describe the pointer tip bending or warping during a case, sometimes after calibration, which leads to inaccurate positioning; some also mention parts coming apart or breaking. No deaths and no injuries were reported, and most cases finished without harm to the patient. There are no recalls name this device, and no reports were filed in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 04546540245106), received between Feb 3, 2017 and Oct 3, 2024 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (21 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.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress21
- Material Twisted/Bent19
- Incorrect Measurement9
- Disassembly8
- Break6
- Material Deformation4
- Fracture3
- Imprecision3
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Patient Involvement16
- No Consequences Or Impact To Patient13
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2024Imprecision; Imprecision
IT WAS REPORTED THAT AFTER CALIBRATION AND VALIDATION, THE LARGE POINTER WAS INACCURATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20363275 ↗MalfunctionAug 7, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING A CASE, IT WAS NOTICED THAT THE TIP OF THE LARGE POINTER WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19935603 ↗MalfunctionJul 1, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A CASE, IT WAS NOTICED THAT THE TIP OF THE LARGE POINTER WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19651425 ↗MalfunctionMay 21, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT DURING A CASE, THE LARGE POINTER WAS INACCURATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19367934 ↗MalfunctionDec 28, 2023Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation
PER THE CUSTOMER THE DEVICE WAS BENT AFTER VALIDATION WHICH CAN LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18409037 ↗MalfunctionDec 12, 2023Incorrect Measurement; Deformation Due to Compressive Stress; Material Twisted/Bent; Incorrect Measurement; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE'S TIP WAS BENT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18310364 ↗MalfunctionNov 27, 2023Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE WAS BENT AND INACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18208589 ↗MalfunctionOct 23, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER THE TIP WAS BENT DURING A SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17983930 ↗MalfunctionOct 23, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER THE TIP WAS BENT DURING A SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17983928 ↗MalfunctionSep 25, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER THE TIP WAS BENT DURING A SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17806573 ↗MalfunctionSep 19, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER THE TIP WAS BENT DURING A SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17773207 ↗MalfunctionAug 28, 2023Incorrect Measurement; Deformation Due to Compressive Stress; Material Deformation; Incorrect Measurement; Deformation Due to Compressive Stress; Material Deformation
PER THE CUSTOMER, THE TIP OF THE LONG POINTER WAS BENT, AND THE DEVICE COULD NOT RECOGNIZE IT ACCURATELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17635615 ↗MalfunctionJul 17, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE WAS BENT DURING THE CASE WHICH CAN LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17331761 ↗MalfunctionJun 28, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CLINICAL SPECIALIST, THE DEVICE WAS BENT DURING A PROCEDURE WHICH CAN LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17222481 ↗MalfunctionMay 30, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER, THE TIP WAS BENT DURING A CASE, WHICH COULD POSSIBLY LEAD TO AN INCORRECT MEASUREMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17020544 ↗MalfunctionApr 24, 2023Material Twisted/Bent; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE BENT DURING THE CASE WHICH CAN LEAD TO IN ACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16794439 ↗MalfunctionJan 19, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER, THE TIP WAS BENT DURING A PROCEDURE WHICH COULD CAUSE INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16202781 ↗MalfunctionDec 12, 2022Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE WAS FOUND TO BE BENT DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15963461 ↗MalfunctionDec 6, 2022Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE WAS BENT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15928339 ↗MalfunctionNov 3, 2022Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE WAS BENT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15721985 ↗MalfunctionOct 11, 2022Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE WAS FOUND BENT AFTER A PROCEDURE WHICH COULD LEAD TO AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15574627 ↗MalfunctionJul 12, 2022Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement; Material Twisted/Bent
PER THE CUSTOMER, THE DEVICE'S TIP WAS BENT DURING A PROCEDURE WHICH COULD LEAD TO AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14987950 ↗MalfunctionMay 16, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
PER THE CUSTOMER, THE POINTER WAS BENT DURING THE CASE WHICH COULD LEAD TO AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14409464 ↗MalfunctionDec 21, 2021Imprecision; Deformation Due to Compressive Stress; Material Twisted/Bent; Imprecision; Deformation Due to Compressive Stress; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE HAND PIECE WAS BENT WHICH CAN LEAD TO AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13056258 ↗MalfunctionMay 25, 2021Fracture; Fracture
DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11878181 ↗
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 18, 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