NA 6002-350-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 04546540503824), received between Feb 10, 2017 and Dec 3, 2024 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 16, 2017Terminated

   Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.

   Z-1216-2018 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE, THE THORACIC PEDICLE FEELER WAS INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836012 ↗
• MalfunctionOct 17, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A NAVIGATED CASE USING THE THORACIC PEDICLE FEELER, IT WAS SHOWING LATERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477865 ↗
• MalfunctionJul 17, 2024Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT THE TIP OF THE THORACIC PEDICLE FEELER WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766779 ↗
• MalfunctionDec 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PER THE CUSTOMER, THE SCREW FELL OUT DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

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

  MAUDE report 18324944 ↗
• MalfunctionDec 14, 2023Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation

  PER THE CUSTOMER, THE TIP OF THE DEVICE WAS LOOSE 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 18324291 ↗
• MalfunctionOct 2, 2023Fracture; Fracture

  PER THE CUSTOMER, THE THORACIC PEDICLE FEELER WAS BROKEN 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 17855344 ↗
• MalfunctionAug 21, 2023Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  PER THE CUSTOMER THE TIP WAS BENT DURING A SURGERY WHICH COULD 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 17582626 ↗
• MalfunctionJul 24, 2023Loose or Intermittent Connection; Incorrect Measurement; Loose or Intermittent Connection; Incorrect Measurement

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS LOOSE WHICH CAN LEAD TO INACCURACIES. 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 17377716 ↗
• MalfunctionJul 21, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  PER THE CUSTOMER, THE DEVICE WAS BENT DURING THE CASE. 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 17369926 ↗
• MalfunctionJul 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PER THE CUSTOMER, A SCREW FROM THE DEVICE FELL INTO PATIENT WOUND AND SURGEON HAD TO FIND AND REMOVE IT. 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 17347083 ↗
• MalfunctionApr 27, 2023Fracture; Fracture

  PER THE CUSTOMER, THE DEVICE'S HANDLE BROKE OFF DURING THE 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 16828708 ↗
• MalfunctionJan 3, 2023Incorrect Measurement; Detachment of Device or Device Component; Incorrect Measurement; Detachment of Device or Device Component

  PER THE CUSTOMER, THE METAL PROBE IS LOOSE, CAUSING INSTABILITY AND INACCURACY. 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 16085207 ↗
• MalfunctionDec 28, 2022Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  PER THE CUSTOMER THE PEDICLE FEELER SNAPPED DURING A CASE. 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 16059347 ↗
• MalfunctionJul 21, 2022Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  PER THE CUSTOMER, THE TIP OF A THORACIC PEDICLE FEELER BROKE OFF INSIDE THE PATIENT AND WAS UNABLE TO BE REMOVED. THE DEVICE FRACTURED AT THE PATIENT'S SACROILIAC JOINT DURING A REVISION SURGERY OF AN ILIAC BOLT THAT HAD BEEN PREVIOUSLY PLACED IN THE PATIENT. PER THE CLINICAL SPECIALIST OBSERVING THE CASE, THE THORACIC PEDICLE FEELER WAS POSITIONED DIRECTLY NEXT TO THE ILIAC BOLT. WHILE ATTEMPTING TO CREATE A PILOT HOLE FOR THE THORACIC PEDICLE FEELER, THE ILIAC BOLT WAS STRUCK, THE GEAR SHAFT BENT AND THE TIP BROKE OFF AS WELL AS THE HANDLE. 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 15076327 ↗
• MalfunctionJan 11, 2022Imprecision; Imprecision

  PER THE CUSTOMER, THE SHAFT 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 13225214 ↗
• MalfunctionNov 22, 2021Imprecision; Imprecision

  PER THE CUSTOMER, THE SHAFT 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 12851753 ↗
• MalfunctionJan 13, 2021Imprecision; Detachment of Device or Device Component; Imprecision; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE'S TIP IS LOOSE CONTRIBUTING TO DIFFICULTY IN MANEUVERING THE INSTRUMENT WHILE IN THE PEDICLE. THE DEVICE WAS UNABLE TO RESPOND IMMEDIATELY TO THE USERS DESIRED DIRECTION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162138 ↗
• MalfunctionNov 16, 2020Imprecision; Detachment of Device or Device Component; Imprecision; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DISTAL TIP OF THE NAVIGATED PEDICLE FINDER IS LOOSE AND SPINS.. 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 10844222 ↗
• MalfunctionOct 19, 2020Imprecision; Unexpected Shutdown; Imprecision; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY WHILE THE SURGEON WAS HOLDING THE DEVICE IN PLACE, IT APPEARED TO BE SHAKING WHILE PLACING PEDICLE SCREWS. 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 10701448 ↗
• MalfunctionJul 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE DEVICE'S DISTAL TIP SNAPPED OFF WHILE INSIDE THE PATIENT'S BONE. THE TIP WAS SUCCESSFUL REMOVED BY THE SURGEON WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10265083 ↗
• MalfunctionDec 3, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SURGEON USING THE DEVICE FOR POINT MATCHING REGISTRATION OF A LUMBAR SPINE PROCEDURE NOTICED THE DEVICE WAS ONLY SHOWING THE DEVICE IN SPACE ON THE SCREEN INSTEAD OF SHOWING THE DEVICE'S VECTOR/ANGLE OF APPROACH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404124 ↗
• MalfunctionOct 22, 2019Image Display Error/Artifact; Detachment of Device or Device Component; Image Display Error/Artifact; Detachment of Device or Device Component

  IT WAS REPORTED THAT IT WAS OBSERVED DURING A PROCEDURE THE TIP OF THE DEVICE WAS DISCOVERED TO BE LOOSE; THIS POSES THE RISK OF INACCURACY AND REVISION SURGERIES. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9221268 ↗
• MalfunctionOct 14, 2019Image Display Error/Artifact; Detachment of Device or Device Component; Image Display Error/Artifact; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING INSPECTION, THE UNIT WAS REPORTED TO HAVE A WOBBLE, LOOSE TIP OR HANDLE; THIS POSES THE RISK OF INACCURACY AND REVISION SURGERIES. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING INSPECTION AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9186541 ↗
• MalfunctionJul 25, 2019Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE. ALTHOUGH REQUESTED, NO INFORMATION WAS AVAILABLE REGARDING WHEN THE REPORTED EVENT WAS OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826346 ↗
• MalfunctionJul 17, 2019Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE INSTRUMENT BROKE AT THE TIP WHILE IN THE PATIENT¿S BONE. THE TIP WAS SUCCESSFULLY REMOVED DURING THE SAME PROCEDURE WITH NO DIFFICULTIES. THERE WERE NO REPORTED ADVERSE CONSEQUENCES, NO SIGNIFICANT PROCEDURE DELAYS AND THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800158 ↗