MOUNTAINEER 288306100Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10705034221441), received between Aug 14, 2013 and May 16, 2025 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (47 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038815 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038806 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038683 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038671 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038646 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038631 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038608 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038601 ↗
• MalfunctionJul 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THE T-HANDLE WITH RATCHET FUNCTION FROM VIPER NO LONGER WORKED. THE RATCHET ARE SPINNING ROUND. THE OPERATION COULD BE COMPLETED WITH A DIFFERENT HANDLE. THERE WERE NO DELAYS AND THERE WAS NO PATIENT HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE INNER DAMAGE OF THE ROTATION MECHANISM CAN EXCEED THE TORQUE LIMITER TESTER AVERAGE. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680697 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB0907. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137454 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB0907. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137408 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 288306100, LOT# GB131018; PRODUCT CODE: 288306100, LOT# GB0907; PRODUCT CODE: 288306100, LOT# GB131018; PRODUCT CODE: 288306100, LOT# GB131018; PRODUCT CODE: 288306100, LOT# GB131018; PRODUCT CODE: 288306100, LOT# GB131018; PRODUCT CODE: 288306100, LOT# GB131018; PRODUCT CODE: 288306100, LOT# GB125164; PRODUCT CODE: 288306100, LOT# GB125164; PRODUCT CODE: 288306100, LOT# GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137402 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB0907. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137401 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB0907. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB131018. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB125164. PRODUCT CODE: 288306100, LOT# GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137396 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED, ON AN UNKNOWN DATE. THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB0907, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB125164, PRODUCT CODE: 288306100, LOT#: GB125164, PRODUCT CODE: 288306100, LOT#: GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137395 ↗
• MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED, ON AN UNKNOWN DATE. THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB0907, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#:  GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB125164, PRODUCT CODE: 288306100, LOT#: GB125164, PRODUCT CODE: 288306100, LOT#: GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137382 ↗
• MalfunctionJul 20, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REVISION FOR REMOVAL OF MOUNTAINEER IMPLANTS (INCLUDING SCREWS AND CONNECTORS), THE RESIDENT DID NOT LOOSEN AND REMOVE THE CROSS CONNECTOR PRIOR TO LOOSENING THE TALL SET SCREW. THE DRIVER TIP BROKE. ANOTHER DRIVER WAS BROUGHT IN TO COMPLETE THE REMOVAL, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO ADVERSE PATIENT CONSEQUENCE. THIS REPORT IS FOR A MOUNTAINEER OCT SPINAL SYSTEM TORQUE DRIVER X15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064306 ↗
• MalfunctionApr 28, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING ON-SITE TESTING AT THE IN-HOUSE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE TORQUE DRIVER DEVICE WAS OUT OF TOLERANCE. ACCORDING TO THE REPORT, THE DEVICE FAILURE MEASUREMENT WAS 3.53 NM BUT THE DEVICE SPECIFICATION MEASUREMENT WAS 2.75 ¿ 3.25 NM. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14243110 ↗
• MalfunctionFeb 16, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET THE X15 TORQUE DRIVER WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545966 ↗
• MalfunctionFeb 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE X15 TORQUE DRIVER WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM TORQUE DRIVER X15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525178 ↗
• MalfunctionNov 4, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE X15 TORQUE DRIVER WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 2.75 ¿ 3.25 NM AND THE TORQUE WAS TESTED HIGH ¿ 3.32 NM. NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM TORQUE DRIVER X15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754711 ↗
• MalfunctionJul 2, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE DRIVER WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH ¿ 3.6. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM TORQUE DRIVER X15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111682 ↗
• MalfunctionMay 4, 2021Calibration Problem; Calibration Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER FAILED CALIBRATION PRIOR TO THE DEVICE BEING SENT FOR DISTRIBUTION. THIS REPORT IS FOR A X15 TORQUE DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769524 ↗
• MalfunctionApr 27, 2021Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE FAILED THE TORQUE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM TORQUE DRIVER X15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732217 ↗
• MalfunctionApr 1, 2021Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE FAILED TORQUE MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM TORQUE DRIVER X15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602589 ↗