MOUNTAINEER 188341200Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034158679), received between Oct 3, 2017 and Feb 20, 2019 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Torn Material” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED: THE SURGERY WAS GOING WELL WITH MOUNTAINEER INSTRUMENTS AND IMPLANTS UNTIL WE GOT TO THE CROSS LINK PORTION, TOWARDS THE END OF THE CASE. THE SURGEON PLACED THE CROSS LINK SET SCREW IN THE HEAD OF THE FAVORED ANGLE SCREW AND FINAL TIGHTENED LIKE IT SUGGESTS IN THE TECHNIQUE. HE THEN CHOSE A CROSS LINK TO FIT OVER THE CROSS LINK SET SCREW, AND STARTED DRIVING A HEX NUT WITH THE HEX NUT DRIVER DOWN CLOCKWISE UNTIL HAND TIGHT. HE THEN GRABBED THE HEX NUT DRIVER AND THE FINAL TIGHTENER DRIVE, BOTH WITH GREY HANDLES, AND STARTED TO LOCK THE NUT WITH THE HEX NUT DRIVER. BEFORE HE WAS ABLE TO FINAL TIGHTEN HE NOTICED THAT THE THREADS OF THE SET SCREW EARLIER PLACED WERE SHEARING OFF AS HE DRIVE THE HEX NUT DRIVER DOWN. HE REPLACED SET SCREW AND REPOSITIONED CROSS LINK AND TRIED TO DRIVE A HEX NUT DOWN A TOTAL OF 4 TIMES AND IT HAPPENED ALL 4 TIMES? HE FOLLOWED THE TECHNIQUE GUIDE EXACTLY. HE DECIDED TO NOT USE THE CROSS LINK DUE TO THIS ISSUE SO HE TOOK OUT/EXPLANTED CROSS LINK SET SCORES, CROSS LINK, AND ALL HEX NUTS. REPLACED THE CROSS LINK SET SCREWS WITH REGULAR SET SCREWS AND LOCKED DOWN CONSTRUCT. THE ONLY THING THAT I COULD THINK OF WAS THAT THE HEX NUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355680 ↗
• InjuryFeb 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED: THE SURGERY WAS GOING WELL WITH MOUNTAINEER INSTRUMENTS AND IMPLANTS UNTIL WE GOT TO THE CROSS LINK PORTION, TOWARDS THE END OF THE CASE. THE SURGEON PLACED THE CROSS LINK SET SCREW IN THE HEAD OF THE FAVORED ANGLE SCREW AND FINAL TIGHTENED LIKE IT SUGGESTS IN THE TECHNIQUE. HE THEN CHOSE A CROSS LINK TO FIT OVER THE CROSS LINK SET SCREW, AND STARTED DRIVING A HEX NUT WITH THE HEX NUT DRIVER DOWN CLOCKWISE UNTIL HAND TIGHT. HE THEN GRABBED THE HEX NUT DRIVER AND THE FINAL TIGHTENER DRIVE, BOTH WITH GREY HANDLES, AND STARTED TO LOCK THE NUT WITH THE HEX NUT DRIVER. BEFORE HE WAS ABLE TO FINAL TIGHTEN HE NOTICED THAT THE THREADS OF THE SET SCREW EARLIER PLACED WERE SHEARING OFF AS HE DRIVE THE HEX NUT DRIVER DOWN. HE REPLACED SET SCREW AND REPOSITIONED CROSS LINK AND TRIED TO DRIVE A HEX NUT DOWN A TOTAL OF 4 TIMES AND IT HAPPENED ALL 4 TIMES? HE FOLLOWED THE TECHNIQUE GUIDE EXACTLY. HE DECIDED TO NOT USE THE CROSS LINK DUE TO THIS ISSUE SO HE TOOK OUT/EXPLANTED CROSS LINK SET SCORES, CROSS LINK, AND ALL HEX NUTS. REPLACED THE CROSS LINK SET SCREWS WITH REGULAR SET SCREWS AND LOCKED DOWN CONSTRUCT. THE ONLY THING THAT I COULD THINK OF WAS THAT THE HEX NUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355350 ↗
• InjuryFeb 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED: THE SURGERY WAS GOING WELL WITH MOUNTAINEER INSTRUMENTS AND IMPLANTS UNTIL WE GOT TO THE CROSS LINK PORTION, TOWARDS THE END OF THE CASE. THE SURGEON PLACED THE CROSS LINK SET SCREW IN THE HEAD OF THE FAVORED ANGLE SCREW AND FINAL TIGHTENED LIKE IT SUGGESTS IN THE TECHNIQUE. HE THEN CHOSE A CROSS LINK TO FIT OVER THE CROSS LINK SET SCREW, AND STARTED DRIVING A HEX NUT WITH THE HEX NUT DRIVER DOWN CLOCKWISE UNTIL HAND TIGHT. HE THEN GRABBED THE HEX NUT DRIVER AND THE FINAL TIGHTENER DRIVE, BOTH WITH GREY HANDLES, AND STARTED TO LOCK THE NUT WITH THE HEX NUT DRIVER. BEFORE HE WAS ABLE TO FINAL TIGHTEN HE NOTICED THAT THE THREADS OF THE SET SCREW EARLIER PLACED WERE SHEARING OFF AS HE DRIVE THE HEX NUT DRIVER DOWN. HE REPLACED SET SCREW AND REPOSITIONED CROSS LINK AND TRIED TO DRIVE A HEX NUT DOWN A TOTAL OF 4 TIMES AND IT HAPPENED ALL 4 TIMES? HE FOLLOWED THE TECHNIQUE GUIDE EXACTLY. HE DECIDED TO NOT USE THE CROSS LINK DUE TO THIS ISSUE SO HE TOOK OUT/EXPLANTED CROSS LINK SET SCORES, CROSS LINK, AND ALL HEX NUTS. REPLACED THE CROSS LINK SET SCREWS WITH REGULAR SET SCREWS AND LOCKED DOWN CONSTRUCT. THE ONLY THING THAT I COULD THINK OF WAS THAT THE HEX NUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355335 ↗
• InjuryFeb 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED: THE SURGERY WAS GOING WELL WITH MOUNTAINEER INSTRUMENTS AND IMPLANTS UNTIL WE GOT TO THE CROSS LINK PORTION, TOWARDS THE END OF THE CASE. THE SURGEON PLACED THE CROSS LINK SET SCREW IN THE HEAD OF THE FAVORED ANGLE SCREW AND FINAL TIGHTENED LIKE IT SUGGESTS IN THE TECHNIQUE. HE THEN CHOSE A CROSS LINK TO FIT OVER THE CROSS LINK SET SCREW, AND STARTED DRIVING A HEX NUT WITH THE HEX NUT DRIVER DOWN CLOCKWISE UNTIL HAND TIGHT. HE THEN GRABBED THE HEX NUT DRIVER AND THE FINAL TIGHTENER DRIVE, BOTH WITH GREY HANDLES, AND STARTED TO LOCK THE NUT WITH THE HEX NUT DRIVER. BEFORE HE WAS ABLE TO FINAL TIGHTEN HE NOTICED THAT THE THREADS OF THE SET SCREW EARLIER PLACED WERE SHEARING OFF AS HE DRIVE THE HEX NUT DRIVER DOWN. HE REPLACED SET SCREW AND REPOSITIONED CROSS LINK AND TRIED TO DRIVE A HEX NUT DOWN A TOTAL OF 4 TIMES AND IT HAPPENED ALL 4 TIMES? HE FOLLOWED THE TECHNIQUE GUIDE EXACTLY. HE DECIDED TO NOT USE THE CROSS LINK DUE TO THIS ISSUE SO HE TOOK OUT/EXPLANTED CROSS LINK SET SCORES, CROSS LINK, AND ALL HEX NUTS. REPLACED THE CROSS LINK SET SCREWS WITH REGULAR SET SCREWS AND LOCKED DOWN CONSTRUCT. THE ONLY THING THAT I COULD THINK OF WAS THAT THE HEX NUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355094 ↗
• InjuryJul 12, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  WHEN THE SURGEON WAS DOING FINAL TIGHTENING WITH TORQUE DRIVERS THE LOCKING SCREW AND THE NUT JUMPED OUT. PATIENT CONSEQUENCE? :NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7680965 ↗
• MalfunctionMar 19, 2018Torn Material; Torn Material

  I WAS COVERING A SPINE CASE AT (B)(6) HOSPITAL ((B)(4)) WITH DR. (B)(6). WE WERE PERFORMING A POSTERIOR SPINE FUSION OF C1-C2 USING MOUNTAINEER. THE CASE WENT WELL UNTIL THE SURGEON WENT TO USE THE FINAL TIGHTENER ON THE SET SCREW ((B)(4)) WHILE TIGHTENING, THE SET SCREW BEGAN TO SPIN FREELY INSIDE THE POLYAXIAL HEAD OF THE LONG SHANK SCREW 3.5MM X 36MM ((B)(4)). THE SURGEON ATTEMPTED TO USE A SEPARATE SET SCREW AND REALIZED THE POLYAXIAL HEAD MUST HAVE STRIPPED. AT THIS POINT WE DECIDED TO BACK OUT THE SCREW AND REPLACE IT WITH THE SAME ITEM. ONCE THIS WAS COMPLETED A NEW SET SCREW THREADED PERFECTLY AND COMPLETED THE CONSTRUCT. I SAVED THE STRIPPED SCREW AND DAMAGED SET SCREWS. 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 Consequences Or Impact To Patient

  MAUDE report 7350247 ↗
• MalfunctionMar 19, 2018Torn Material; Torn Material

  I WAS COVERING A SPINE CASE AT (B)(6) HOSPITAL ((B)(4)) WITH DR. (B)(6). WE WERE PERFORMING A POSTERIOR SPINE FUSION OF C1-C2 USING MOUNTAINEER. THE CASE WENT WELL UNTIL THE SURGEON WENT TO USE THE FINAL TIGHTENER ON THE SET SCREW (1883-41-200) WHILE TIGHTENING, THE SET SCREW BEGAN TO SPIN FREELY INSIDE THE PILYAXIAL HEAD OF THE LONG SHANK SCREW 3.5MM X 36MM (1886-20-336). THE SURGEON ATTEMPTED TO USE A SEPARATE SET SCREW AND REALIZED THE POLYAXIAL HEAD MUST HAVE STRIPPED. AT THIS POINT WE DECIDED TO BACK OUT THE SCREW AND REPLACE IT WITH THE SAME ITEM. ONCE THIS WAS COMPLETED A NEW SET SCREW THREADED PERFECTLY AND COMPLETED THE CONSTRUCT. I SAVED THE STRIPPED SCREW AND DAMAGED SET SCREWS. 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 Consequences Or Impact To Patient

  MAUDE report 7350161 ↗
• MalfunctionMar 7, 2018Torn Material; Torn Material

  IN A POSTERIOR CERVICAL C2-C4 FUSION DR. (B)(6) ATTEMPTED TO FINAL TIGHTEN THE 188341200 TALL SET SCREW ON THE LONG SHANK SCREW 188320328 AND IT WOULD NOT TIGHTEN; JUST SPINNING AND NOT ENGAGING THE SCREW THREADS. MULTIPLE DIFFERENT 188341200 SET SCREWS WERE USED BUT NONE THREADED. IT WAS UNKNOWN BUT POSSIBLE THE TORQUE WAS OUT OF CALIBRATION AND DAMAGED THE SCREW. THE AFFECTED 188320328 SCREW AND SEVERAL OF ATTEMPTED TALL SET SCREWS WITH NUTS 188341100 AND 188341200 ARE BEING RETURNED FOR INVESTIGATION AS WELL AS ALL TORQUE DRIVERS TO ENSURE PATIENT SAFETY. THERE WAS ALSO A 188341028 CROSS CONNECTOR AT THIS LEVEL BUT WAS UNLIKELY TO HAVE CAUSED THE PROBLEM. THE SURGERY FINISHED WITHOUT FURTHER INCIDENT AFTER NEW TRAYS WERE OPENED AND A 188320328 SCREW WAS PLACED. REPLACEMENT P.O. FOR INSTRUMENTS 7400049279. PATIENT CONSEQUENCE?: NO. PATIENT CONSEQUENCE DESCRIPTION:DELAY IN SURGERY TO ACQUIRE REPLACEMENT INSTRUMENTS AND IMPLANTS. ACTION TAKEN FOR PROCEDURE:NEW TRAYS OPENED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

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

  MAUDE report 7320201 ↗
• MalfunctionMar 6, 2018Torn Material; Torn Material

  IN A POSTERIOR CERVICAL C2-C4 FUSION DR.(B)(6) ATTEMPTED TO FINAL TIGHTEN THE 188341200 TALL SET SCREW ON THE LONG SHANK SCREW 188320328 AND IT WOULD NOT TIGHTEN; JUST SPINNING AND NOT ENGAGING THE SCREW THREADS. MULTIPLE DIFFERENT 188341200 SET SCREWS WERE USED BUT NONE THREADED. IT WAS UNKNOWN BUT POSSIBLE THE TORQUE WAS OUT OF CALIBRATION AND DAMAGED THE SCREW. THE AFFECTED 188320328 SCREW AND SEVERAL OF ATTEMPTED TALL SET SCREWS WITH NUTS 188341100 AND 188341200 ARE BEING RETURNED FOR INVESTIGATION AS WELL AS ALL TORQUE DRIVERS TO ENSURE PATIENT SAFETY. THERE WAS ALSO A 188341028 CROSS CONNECTOR AT THIS LEVEL BUT WAS UNLIKELY TO HAVE CAUSED THE PROBLEM. THE SURGERY FINISHED WITHOUT FURTHER INCIDENT AFTER NEW TRAYS WERE OPENED AND A 188320328 SCREW WAS PLACED. REPLACEMENT P.O. FOR INSTRUMENTS 7400049279. PATIENT CONSEQUENCE? :NO. PATIENT CONSEQUENCE DESCRIPTION:DELAY IN SURGERY TO ACQUIRE REPLACEMENT INSTRUMENTS AND IMPLANTS. ACTION TAKEN FOR PROCEDURE:NEW TRAYS OPENED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

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

  MAUDE report 7318370 ↗
• MalfunctionFeb 9, 2018Torn Material; Torn Material

  IT WAS REPORTED SURGEON COULD NOT FINAL TIGHTEN THE OUTER NUTS ON TOP OF THE CROSSLINK BECAUSE THE TALL SET SCREW THREADS HAD BEEN SHEARED AND HE COULD NOT FINAL TIGHTEN THE INNER CROSSLINK SET SCREW. APPEARS THE SCREW AND THE INNER SET SCREW WERE CROSS THREADED.

  Patient problems: Not Applicable

  MAUDE report 7260775 ↗
• MalfunctionFeb 9, 2018Torn Material; Torn Material

  IT WAS REPORTED SURGEON COULD NOT FINAL TIGHTEN THE OUTER NUTS ON TOP OF THE CROSSLINK BECAUSE THE TALL SET SCREW THREADS HAD BEEN SHEARED AND HE COULD NOT FINAL TIGHTEN THE INNER CROSSLINK SET SCREW. APPEARS THE SCREW AND THE INNER SET SCREW WERE CROSS THREADED.

  Patient problems: Not Applicable

  MAUDE report 7260591 ↗
• MalfunctionFeb 9, 2018Torn Material; Torn Material

  IT WAS REPORTED SURGEON COULD NOT FINAL TIGHTEN THE OUTER NUTS ON TOP OF THE CROSSLINK BECAUSE THE TALL SET SCREW THREADS HAD BEEN SHEARED AND HE COULD NOT FINAL TIGHTEN THE INNER CROSSLINK SET SCREW. APPEARS THE SCREW AND THE INNER SET SCREW WERE CROSS THREADED.

  Patient problems: Not Applicable

  MAUDE report 7260397 ↗
• MalfunctionNov 10, 2017Torn Material; Torn Material

  WHEN TORQUING DOWN THE OUTER NUT ON THE H/H CONN PLATE, THE DRIVER AND NUT KEPT SHEARING OFF THE TOP OF THE INNER SCREW. THE SURGEON WAS NOT ABLE TO USE THE H/H CONN PLATE IN HIS CONSTRUCT BECAUSE OF THIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017613 ↗
• MalfunctionOct 3, 2017Torn Material; Torn Material

  DOCTOR PERFORMED A C2-C7 POSTERIOR CERVICAL FUSION WITH THE MOUNTAINEER SYSTEM ON (B)(6) 2017. ONCE ALL THE SCREWS WERE IN PLACE, HE PLACED THE RODS AND SET SCREWS. HE DECIDED TO DO A CROSS LINK AT THE C5 LEVEL. HE INSERTED THE HEAD-TO-HEAD INNER SCREWS AT THIS LEVEL. A CROSS LINK WAS CHOSEN AND PLACED. WHEN HE TRIED TO PUT THE HEAD-TO-HEAD OUTER NUTS ON, IT WAS DECIDED THE CROSS LINK NEEDED TO BE BENT. ONCE IT WAS BENT, HE TRIED TO PUT THE OUTER NUTS ON AGAIN. HE SUCCESSFULLY GOT BOTH NUTS OVER THE CROSS LINK. HE THEN PROCEED TO FINAL TIGHTEN THE OUTER NUTS, ONE SIDE TORQUED OUT WITH NO PROBLEMS. WHEN TRYING TO FINAL TIGHTEN THE OTHER SIDE, DOCTOR STATED THE HEAD-TO-HEAD INNER SCREW SHEARED OFF. AT THIS POINT, HE REMOVED THE CROSS LINK AND HEAD-TO-HEAD INNER SCREWS AND OUTER NUTS. HE DECIDED AGAINST PLACING A NEW CROSSLINK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6910559 ↗