MOUNTAINEER 188342200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034158693), received between Mar 8, 2018 and Dec 9, 2021 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE FOR ADJACENT LEVEL FIXATION AND EXTENSION OF THE CONSTRUCT, THE SET SCREW WAS FOUND TO BE OUTSIDE THE SCREW HEAD. THE INITIAL C5-C6 POSTERIOR CERVICAL FIXATION PROCEDURE THAT WAS PERFORMED IN (B)(6) 2020. NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968758 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191727 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191709 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191674 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191566 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191377 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) MNTR INNER SCREW. THIS IS REPORT 2 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190801 ↗
• InjurySep 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE POST SURGERY X-RAY SHOWED A LOOSENED MOUNTAINEER SET SCREW PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION: REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:REVISION SURGERY ON (B)(6) 2018. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7891396 ↗
• MalfunctionMar 8, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DR. (B)(6) PERFORMED A C3-T1 FUSION ON THE PATIENT ON (B)(6) 2017. LATERAL MASS SCREWS, 3.5MM IN DIAMETER AND 12-14MM IN LENGTH, WERE PLACED BILATERALLY C3-C6, SKIPPING C7, AND BILATERALLY AT T1, 4.0MM IN DIAMETER AND 30MM IN LENGTH M/L SCREWS. 10 MOUNTAINEER SET SCREWS AND 1 3.5X200MM TI ROD WERE PLACED IN THE CONSTRUCT IN TYPICAL FASHION. SET SCREWS WERE FINAL TIGHTENED AND THE SURGERY CONCLUDED SUCCESSFULLY. ON (B)(6) 2018, THE PATIENT ARRIVED AT MAYO FOR REVISION FUSION. THE RIGHT T1 SET SCREW WAS NOTED ON X-RAY TO BE FLOATING ABOVE THE POLYAXIAL HEAD. ALL OTHER SCREWS AND SET SCREWS WERE IN THEIR ORIGINAL LOCATION. DR. ELDER REMOVED THE REMAINING SET SCREWS AND THE RIGHT T1 M/L SCREW. THE REMAINING SCREWS IN THE CONSTRUCT WERE CHECKED FOR ADEQUATE BONEY FIXTION. DR. ELDER PROCEEDED TO ADD 3.5X26MM MOUNTAINEER SCREWS TO C2 BILATERALLY AND 4.35X35/30 M/L SCREWS BILATERALLY AT T2, AND REMOVED ALL OF THE LATERAL MASS SCREWS C3-C6, REPLACING THEM WITH 4.0X14MM M/L AND GREEN SCREWS. DR. ELDER ALSO REMOVED THE ORIGINAL T1 SCREWS BILATERALLY AND REPLACED THEM WITH 4.35X25/30MM M/L SCREWS. 14 SET SCREWS AND 2 3.5X120MM TI RODS WERE PLACED BILATERALLY. THE SET SCREWS WERE FINAL TIGHTENE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324314 ↗