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MOUNTAINEER 188319430Recalls & reported problems

Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.0 x 30mm · Class 2 · Implant

All models of MOUNTAINEER (51)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034157924), received between Mar 8, 2018 and Aug 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

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

Device problems

  • Disconnection1
  • Loose or Intermittent Connection1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 20, 2019Disconnection; Disconnection

    IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL SPINAL FUSION PROCEDURE TREATING ATLANTOAXIAL SUBLUXATION, STABILIZING C2, ON (B)(6) 2019. AFTER THE SCREW (1883.19.430) WAS INSERTED, THE SURGEON TRIED TO DETACH THE SCREW FROM A SCREWDRIVER. BECAUSE S/HE FELT DISCOMFORT ON THE REMOVAL, A LITTLE MORE LOAD WAS ADDED TO THE DEVICES. THEN, THE SCREWDRIVER WAS DISCONNECTED FROM THE SCREW, AND COMPONENTS INSIDE THE SCREWHEAD CAME OFF. THE SURGERY WAS COMPLETED WITH A REPLACEMENT LESS THAN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8910697 ↗
  • 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. (B)(6) 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. (B)(6) 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. (B)(6) 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 TIGHT

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7323915 ↗

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Sources and updates

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