MOUNTAINEER 188320320Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 20mm · Class 2 · Implant
All models of MOUNTAINEER (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034158105), received between Apr 23, 2018 and Apr 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Torn Material” (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 16, 2026.
Most reported problems
Device problems
- Torn Material1
Patient problems
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2018Torn Material; Torn Material
IT WAS REPORTED AFTER IMPLANTING ALL SCREWS AND RODS, (B)(6) WAS FINAL TIGHTENING THE OUTER NUT FOR THE CROSSLINK AND IT PULLED THE INNER SET SCREW OUT OF THE SCREW HEAD. HE THOUGHT IT WAS A DEFECTIVE SET SCREW SO HE CHANGED OUT THE INNER SET SCREW. WHEN HE PUT ON THE OUTER NUT AND STARTED TO FINAL TIGHTEN IT, IT PULLED OUT THE INNER SET SCREW AGAIN. HE TRIED THIS AGAIN WITH THE SAME OUTCOME. AT THIS POINT HE EXAMINED THE THREADS IN THE SCREW HEAD AND REALIZED THAT THE THREADS WERE GONE ON ONE SIDE OF THE TULIP. HE THEN HAD TO REMOVE THE ROD AND CHANGE OUT THE ACTUAL SCREW. AFTER CHANGING OUT THE SCREW, EVERYTHING LOCKED DOWN AS IT SHOULD. 30 MINUTE DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7450888 ↗
Other Orthosis, cervical pedicle screw spinal fixation devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- YUKON OCT Spinal System 7601-05030VB Spine LLC · Orthosis, cervical pedicle screw spinal fixation15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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