MOUNTAINEER 188319525Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 25mm · 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 10705034158044), received between Sep 1, 2017 and Sep 1, 2017 — 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2017Break; Break
ON (B)(6) 2017, SURGERY FOR SPONDYLOLISTHESIS WAS PERFORMED USING THE MOUNTAINEER SYSTEM. THE FIXED AREA WAS C7 ¿ T1. THE FOLLOWING ISSUES ARE CONFIRMED DURING THE SURGERY. - THE SURGEON MADE THE HOLE BY USING 4.0 MM TAP. - HE TRIED TO INSERT THE 4.35 MM SCREW USING THE SCREW DRIVER (PART#: 288304000), HOWEVER, TIP OF THE SCREW DRIVER GOT BROKEN AND THEN THE BROKEN TIP WAS BURIED INSIDE THE SCREW. - HE ATTACHED THE SCREW TO THE ROD AND SET SCREW TOGETHER, AND THEN PULLED THE SCREW OUT. - EVENTUALLY THE SCREW GOT BROKEN. THERE WERE NO BROKEN PARTS FOUND LEFT IN THE BODY AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6839766 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page