MOUNTAINEER 188319422Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4 x 22mm · 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 10705034157887), received between May 3, 2018 and May 3, 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.
MalfunctionMay 3, 2018Break; Break
ON (B)(6) 2018, THE SURGERY FOR UNKNOWN REASONS WAS PERFORMED USING THE MOUNTAINEER SPINE SYSTEM. THE FIXED AREA WAS C7 (RIGHT). DURING THE SURGERY, THE FOLLOWING EVENT WAS CONFIRMED BY THE SURGEON. HE INSERTED THE REPORTED SCREW ((B)(4)) TO C7 (RIGHT) AFTER ATTACHING THIS SCREW TO THE SCREWDRIVER. HE TEMPORARILY FELT DIFFICULTIES PULLING OUT THE SCREWDRIVER, BUT HE COULD DO IT. WHEN PLACING THE ROD, HE NOTICED THAT THE HEAD OF THE SCREW WAS BROKEN. HE EXTRACTED THE BROKEN SCREW AND REPLACED IT WITH A NEW ONE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7482843 ↗
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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