MOUNTAINEER 188319328Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 28mm · Class 2 · Implant
All models of MOUNTAINEER (51)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034157696), received between Apr 26, 2018 and Apr 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionApr 26, 2018Break; Break
ON (B)(6) 2018, THE SPINAL FUSION SURGERY FOR ODONTOID PROCESS FRACTURE WAS PERFORMED BY USING THE MOUNTAINEER SPINE SYSTEM. THE FIXED AREA WAS C2-C3. THE SURGEON NOTICED THAT THE SURGEON HAD A DIFFICULTY IN TAKING THE DRIVER BIT OFF FROM ONE SCREW. WHEN THE ROD WAS PLACED, THE ROD COULD NOT BE PLACED WITHIN THE HEAD. WHEN CHECKED, IT WAS FOUND THAT THE CLAMP PART BETWEEN THE SCREW HEAD AND SCREW WAS STANDING OUT. ANOTHER NEW SCREW WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED WITH A DELAY (LESS THAN 30 MINUTES), AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7465215 ↗
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 79-2002Orthofix 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
- 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
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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