MOUNTAINEER 188319326Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034157689), received between Jun 26, 2018 and Dec 6, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2023, THE DEVICES¿ INNER CORE WAS EXPULSION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR MNTR M/L SCREW 3.5 DIA X 26 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277383 ↗
• InjuryOct 3, 2018Break; Break

  THE FOLLOWING WAS REPORTED: POST-OPERATIVE SCREW BREAKAGE. THE PATIENT ACCEPTED ATLANTOOCCIPITAL FUSION AND DECOMPRESSION ON (B)(6) 2017. NO ANOMALY WAS OBSERVED IN PROCEDURE. THE PATIENT FELT PAIN WHEN RAISE HER HEAD ON (B)(6) 2018. THE PATIENT RETURNED HOSPITAL AND X-RAY REPORT INDICATED SCREW BROKE. THE REVISION SURGERY WAS OPERATED AND BROKEN SCREW WAS REMOVED ON (B)(6) 2018. THEN PATIENT CONDITION CHANGED BETTER.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7932206 ↗
• InjuryJun 26, 2018Torn Material; Torn Material

  ON (B)(6) 2018, THE EMERGENCY SURGERY FOR DISLOCATION FRACTURE AT C7 WAS PERFORMED BY USING THE MOUNTAINEER SPINE SYSTEM. DURING THE SURGERY, AT THE TIME OF SET SCREW INSERTION, IT WAS FOUND THAT THE INTERNAL HEAD OF THE SCREW (188319326) WAS CROSS-THREADED. THE SURGEON TRIED TO TIGHTEN THE SCREW IN QUESTION WITH ANOTHER NEW SET SCREW, BUT HE COULD NOT TIGHTEN IT. AS HE NOTICED THAT THE HEAD OF THE SCREW IN QUESTION WAS BROKEN, HE EXTRACTED THE BROKEN PIECES FROM THE PATIENT¿S BODY AND REPLACED THE SCREW IN QUESTION WITH ANOTHER SAME SIZE OF THE SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED, BUT IT WAS DELAYED WITHIN 30 MINUTES DUE TO THIS EVENT. NO BROKEN PIECES WERE FOUND LEFT IN THE PATIENT¿S BODY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. WHILE THE SURGEON IS CONCERNED ABOUT DETERIORATION OF THE PRODUCT, HE IS REQUESTING US TO INVESTIGATE ON THE ROOT CAUSE OF THIS EVENT.

  Patient problems: Not Applicable

  MAUDE report 7637685 ↗