MOUNTAINEER 188318322Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 22mm · Class 2 · Implant
All models of MOUNTAINEER (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034157221), received between Oct 23, 2018 and Oct 23, 2018 — classified as 2 injuries.
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
Device problems
- Break2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2018Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A C4-7 POST CERVICAL FUSION WITH AN UNKNOWN MOUNTAINEER SCREWS ON (B)(6) 2018. AFTER SIX (6) MONTHS, THE PATIENT HAD A FOLLOW-UP X-RAY THAT SHOWED A LEFT C7 FAVORED ANGLE SCREW WAS BROKEN MID-SHAFT. THE SURGEON HAS ORDERED A COMPUTED TOMOGRAPHY (CT) SCAN WHETHER THE SEGMENT HAD FUSED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Code Available
MAUDE report 7996759 ↗InjuryOct 23, 2018Break; Break
IT WAS REPORTED THAT THE CONSTRUCT WAS C4-C7 POSTERIOR SPINE FUSION. PATIENT HAD ACDF C4-7 12 MONTHS PRIOR TO POSTERIOR SURGERY. DR. NOTICED C7 LEFT SCREW IS BROKEN INSIDE VERTEBRAE DURING 6MO FOLLOW UP X-RAYS. IMPLANT IS A MOUNTAINEER 3.5 X 22MM F/A SCREW BROKEN IN C7. SURGEON PLAN IS TO ORDER A CT FOR THE PATIENT AND MAKE A PLAN FROM THERE.
Patient problems: No Code Available
MAUDE report 7996608 ↗
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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