MOUNTAINEER 288314000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034221847), received between Jan 11, 2018 and Nov 20, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A SPINAL FUSION PROCEDURE, SURGEON PLACED A MTNR PLATE WITH SCREWS, PERFORMED FINAL TIGHTENING OF PLATE SCREWS WITH THE OC UNIV JOINT TORQUE DRIVER, AND THE TIP OF DRIVER SNAPPED. TIP WAS RETRIEVED AND STRAIGHT TORQUE DRIVER HAD TO BE USED FOR FINAL TIGHTENING. THE PROCEDURE CONTINUED ON. THERE WAS NO PATIENT OUTCOME. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733160 ↗
• MalfunctionSep 14, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE DRIVER WAS OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE MOUNTAINEER OCT SPINAL SYSTEM OC UNIV. JOINT TORQUE DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746518 ↗
• MalfunctionApr 27, 2021Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN IRELAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732636 ↗
• MalfunctionDec 31, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TORQUE WRENCH WAS TESTED MULTIPLE TIMES AND EACH TIME IT SHOWED THAT IT WAS OUT OF TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE UNIVERSAL JOINT TORQUE DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535148 ↗
• MalfunctionAug 7, 2019Mechanical Problem; Mechanical Problem

  DURING OCCIPIT TO C4 FUSION WITH MOUNTAINEER, SURGEON ATTEMPTED TO FINAL TIGHTEN RIGHT SIDE OCCIPITAL SET SCREW (188362025) ON THE OCCIPITAL PLATE (188362031) AND FELT THE FINAL TIGHTENER (288314000) STRIPPING THE SET SCREW. A COUNTERTORQUE AND ROD HOLDER WERE USED AT THE TIME OF FINAL TIGHTENING FOR STABILIZATION. HE COULD NOT GET ANOTHER OC SET SCREW TO ENGAGE WITH THE PLATE AGAIN, AND BELIEVED THE ROD CAPTURING HEAD ON THE PLATE WAS BROKEN, OR SPLAYED. THE SET SCREW THAT STRIPPED WAS INADVERTENTLY DISCARDED. THE SURGEON HAD TO REMOVE ALL SET SCREWS AND THE RODS IN ORDER TO ACCESS THE PLATE TO REMOVE IT. IT WAS REPLACED WITH THE SAME SIZE AND ANOTHER TRAY WAS OPENED FOR A SECOND FINAL TIGHTENER. IT IS SUSPECTED THIS WAS CAUSED BY AN OUT-OF-CALIBRATION FINAL TIGHTENER. I AM ALSO REQUESTING EXCHANGES FOR ALL MOUNTAINEER FINAL TIGHTENERS IN AN ABUNDANCE OF CAUTION. CUSTOMER REFERENCE/PO/SERVICE: (B)(6). WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: YES. IF YES, NUMBER OF MINUTES: 30. ACTION TAKEN WHEN EVENT OCCURRED?: OPENED A SECOND TRAY TO ACCESS ANOTHER PLATE AND FINAL TIGHTENER. WAS PROCEDURE SUCCESSFULLY COMPLETED?: YES. WERE FRAGMENTS GENERATED?: UNKNOWN. IF YES, WERE THEY R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8869503 ↗
• MalfunctionAug 7, 2019Mechanical Problem; Mechanical Problem

  DURING OCCIPIT TO C4 FUSION WITH MOUNTAINEER, SURGEON ATTEMPTED TO FINAL TIGHTEN RIGHT SIDE OCCIPITAL SET SCREW (188362025) ON THE OCCIPITAL PLATE (188362031) AND FELT THE FINAL TIGHTENER (288314000) STRIPPING THE SET SCREW. A COUNTERTORQUE AND ROD HOLDER WERE USED AT THE TIME OF FINAL TIGHTENING FOR STABILIZATION. HE COULD NOT GET ANOTHER OC SET SCREW TO ENGAGE WITH THE PLATE AGAIN, AND BELIEVED THE ROD CAPTURING HEAD ON THE PLATE WAS BROKEN, OR SPLAYED. THE SET SCREW THAT STRIPPED WAS INADVERTENTLY DISCARDED. THE SURGEON HAD TO REMOVE ALL SET SCREWS AND THE RODS IN ORDER TO ACCESS THE PLATE TO REMOVE IT. IT WAS REPLACED WITH THE SAME SIZE AND ANOTHER TRAY WAS OPENED FOR A SECOND FINAL TIGHTENER. IT IS SUSPECTED THIS WAS CAUSED BY AN OUT-OF-CALIBRATION FINAL TIGHTENER. I AM ALSO REQUESTING EXCHANGES FOR ALL MOUNTAINEER FINAL TIGHTENERS IN AN ABUNDANCE OF CAUTION. CUSTOMER REFERENCE/PO/SERVICE: (B)(6), WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: YES, IF YES, NUMBER OF MINUTES: 30, ACTION TAKEN WHEN EVENT OCCURRED?: OPENED A SECOND TRAY TO ACCESS ANOTHER PLATE AND FINAL TIGHTENER. WAS PROCEDURE SUCCESSFULLY COMPLETED?: YES, WERE FRAGMENTS GENERATED?: UNKNOWN, IF YES, WERE THEY R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8869349 ↗
• MalfunctionAug 1, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE MOUNTAINEER OCT SPINAL SYSTEM OC UNIVERSAL JOINT TORQUE DRIVER WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 2.25-2.75. THE TORQUE TESTED HIGH ¿ 3.213-3.475. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8852213 ↗
• MalfunctionJul 17, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING RECEIVING INSPECTION, 6.0 NM TORQUE LIMITING HANDLE WAS FOUND TO BE OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8797981 ↗
• MalfunctionJan 11, 2018Break; Break

  IT WAS REPORTED THAT A TORQUE HANDLE 2883-14-000 ¿ LOT GB70352 WAS RETURNED TO THE CHARLOTTE NC FSL FROM HOSPITAL ((B)(4)) AND INSPECTED PER INSPECTION REQUIREMENTS. THE TORQUE DRIVER COULD NOT BE TESTED DUE TO THE STAR TIP BEING NOT FUNCTIONAL/WORN. REQUIRED RANGE: LOW-2.25NM, HI- 2.75NM. ACTUAL RESULT N/A, CASE # (B)(4), PART# 2883-14-000, LOT# GB70352, QTY ¿ 1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7182060 ↗