MOUNTAINEER 188362037Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034158884), received between Feb 1, 2018 and May 19, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionMay 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE (RIGHT SIDE), THE PLATE WING TIPS WERE TOO BENT. THERE WAS NO REPORTED PATIENT OR USER HERM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221379 ↗
• MalfunctionMay 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE (RIGHT SIDE), THE PLATE WING TIPS WERE TOO BENT. THERE WAS NO REPORTED PATIENT OR USER HERM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221378 ↗
• MalfunctionMay 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE (RIGHT SIDE), THE PLATE WING TIPS WERE TOO BENT. THERE WAS NO REPORTED PATIENT OR USER HERM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221373 ↗
• MalfunctionFeb 19, 2024Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN SURGERY, THE PLATE IN QUESTION BROKE OFF WHEN IT WAS BENT. ANOTHER PLATE OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 37MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731563 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A OCCIPITO CERVICAL FUSION PROCEDURE OF C5 WITH MOUNTAINEER OCT, A OCT PLATE WAS MEASURED AND SELECTED. IT WAS ATTEMPTED TO FOLLOW PROCEDURE OF CONTOURING, AT THE BACK TABLE, THE SUPERIOR TIP OF THE PLATE (AT BENDING ZONE) WITH THE OCT PLATE BENDER. WITH GENTLE PRESSURE TO BEND, THE TIP OF THE PLATE SNAPPED OFF AT BENDING ZONE. NEW PLATE WAS SELECTED (37MM) AND WAS ABLE TO PROPERLY BEND THE PLATE TO PROCEED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MNTR OC PLATE MEDIUM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335827 ↗
• MalfunctionFeb 3, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SURGEON NEEDED TO BEND THE OCCIPITAL PLATE FOR A PROPER FIT. THE APPROPRIATE INSTRUMENTS AND TECHNIQUE WERE USED TO BEND IT, BUT UPON APPLYING THE SLIGHTEST FORCE, THE PLATE BROKE. THE PLATE WAS BENT ON A SIDE TABLE AND NOT INSIDE THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A MOUNTAINEER OCCIPITAL PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274295 ↗
• MalfunctionJun 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, ON AN UNKNOWN PROCEDURE, WHEN BENDING PLATE SNAPPED AT THE WING WITH LITTLE FORCE APPLIED. THERE WAS A 5 MINUTE SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT CONSEQUENCE ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700728 ↗
• MalfunctionFeb 26, 2018Break; Break

  OC PLATES BROKE WHILE BENDING. OC PLATE ROD CAPTURE WAS SPLAYED AND COULD NOT LOCK A SET SCREW. ADDITIONAL INFORMATION RECEIVED FROM REP: THE FIRST PLATE HAD THE ISSUE WITH THE SPLAYING OF THE RIGHT ROD CAPTURE (TULIP HEAD). THE 2ND AND 3RD PLATES WERE THEN BROKEN WHEN TRYING TO CONTOUR BECAUSE WE HAD TO REMOVE THE FIRST PLATE. SURGEON COMPLETED THE CASE, THE EVENT PROBABLY DELAYED THE CASE ABOUT 30 MINUTES. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7297302 ↗
• MalfunctionFeb 1, 2018Torn Material; Torn Material

  OHE OF THE MOUNTAINEER OC INNER SCREWS WOULDN¿T SEAT PROPERLY AT THE END OF THE CASE, DURING FINAL TIGHTENING. DR. (B)(6) HAD TO REMOVE THE PLATE, WASHER, AND OCCIPITAL SCREWS. HE THEN REPLACED ALL THE ITEMS WITH NEW IMPLANTS. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: ADDED TIME (20 MINUTES) TO SURGERY, NO PATIENT INJURY. ACTION TAKEN FOR PROCEDURE: ASKED SURGEON TO REPLACE THE FIRST STRIPPED OC SETSCREW. HE ATTEMPTED THIS THREE TIMES BEFORE DECIDING TO REMOVE AND REPLACE THE OCCIPITAL IMPLANTS.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7234147 ↗