MOUNTAINEER 188362025Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034158853), received between Aug 4, 2017 and Mar 9, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY OF A POSTERIOR SPINAL FUSION ON (B)(6) 2022. THE ORIGINAL PROCEDURE WAS DONE ON (B)(6) 2022. ON AN UNKNOWN DATE FOLLOWING THE INITIAL PROCEDURE, THE MOUNTAINEER OC PLATE, TWO (2) RODS, AND TWO (2) SET SCREWS POPPED OUT. BOTH RODS POPPED OUT BUT WERE STILL IN THE CERVICAL PORTION. IT WAS NOTED THAT THE PATIENT DID NOT WEAR A NECK BRACE ALL THE TIME AND THE NECK MAY HAVE BEEN HYPEREXTENDED IN THE ORIGINAL CASE. THE DOCTOR HAD ONLY PUT TWO SCREWS ON THE PLATE. THE ANGLE WAS BAD, AND THE THIRD SCREW COULD NOT BE ADDED. PATIENT WAS REVISED TO AN OCCIPITAL TO T2 FUSION. IN THE REVISION, THE SURGEON PUT IN ALL THREE SCREWS. THIS REPORT IS FOR A MOUNTAINEER OCCIPITAL SCREW. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13712052 ↗
• InjuryMar 9, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY OF A POSTERIOR SPINAL FUSION ON (B)(6) 2022. THE ORIGINAL PROCEDURE WAS DONE ON (B)(6) 2022. ON AN UNKNOWN DATE FOLLOWING THE INITIAL PROCEDURE, THE MOUNTAINEER OC PLATE, TWO (2) RODS, AND TWO (2) SET SCREWS POPPED OUT. BOTH RODS POPPED OUT BUT WERE STILL IN THE CERVICAL PORTION. IT WAS NOTED THAT THE PATIENT DID NOT WEAR A NECK BRACE ALL THE TIME AND THE NECK MAY HAVE BEEN HYPEREXTENDED IN THE ORIGINAL CASE. THE DOCTOR HAD ONLY PUT TWO SCREWS ON THE PLATE. THE ANGLE WAS BAD, AND THE THIRD SCREW COULD NOT BE ADDED. PATIENT WAS REVISED TO AN OCCIPITAL TO T2 FUSION. IN THE REVISION, THE SURGEON PUT IN ALL THREE SCREWS. THIS REPORT IS FOR A MOUNTAINEER OCCIPITAL SCREW. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13711973 ↗
• MalfunctionAug 4, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING FINAL TIGHTENING OF OCCIPITAL PLATE THE SET SCREWS WOULD NOT LOCK IN AND APPEARED TO BE CROSS THREADED. SEVERAL SET SCREWS WERE TRIED, IN THE END A NEW 31MM PLATE, SET SCREWS AND FINAL TIGHTENER WERE USED AND THE CASE WAS ABLE TO BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768851 ↗
• MalfunctionAug 4, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING FINAL TIGHTENING OF OCCIPITAL PLATE THE SET SCREWS WOULD NOT LOCK IN AND APPEARED TO BE CROSS THREADED. SEVERAL SET SCREWS WERE TRIED, IN THE END A NEW 31MM PLATE, SET SCREWS AND FINAL TIGHTENER WERE USED AND THE CASE WAS ABLE TO BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768830 ↗
• MalfunctionAug 4, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING FINAL TIGHTENING OF OCCIPITAL PLATE THE SET SCREWS WOULD NOT LOCK IN AND APPEARED TO BE CROSS THREADED. SEVERAL SET SCREWS WERE TRIED, IN THE END A NEW 31MM PLATE, SET SCREWS AND FINAL TIGHTENER WERE USED AND THE CASE WAS ABLE TO BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768803 ↗
• MalfunctionAug 4, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING FINAL TIGHTENING OF OCCIPITAL PLATE THE SET SCREWS WOULD NOT LOCK IN AND APPEARED TO BE CROSS THREADED. SEVERAL SET SCREWS WERE TRIED, IN THE END A NEW 31 MM PLATE, SET SCREWS AND FINAL TIGHTENER WERE USED AND THE CASE WAS ABLE TO BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768767 ↗