MOUNTAINEER 188319320Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034157658), received between Oct 3, 2017 and Oct 3, 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2017Break; Break
ON (B)(6) 2015, SURGERY FOR CERVICAL SPINE TRAUMA WAS PERFORMED USING THE MOUNTAINEER SYSTEM. THE FIXED AREA WAS C4 - C6. BECAUSE OF BETTER BONE GROWTH, ON (B)(6) 2017, REMOVAL SURGERY WAS PERFORMED DUE TO SYNOSTOSIS. DURING THE SURGERY, THE SURGEON TOOK THE FOLLOWING PROCEDURES. WHEN HE REMOVED TWO SET SCREWS ON THE LEFT SIDE, IT WAS CONFIRMED THAT THE HEAD PART OF THE SCREW (PART #: 188319320, LOT#: APFCWP) AT C6 WAS LOOSENED. THEN, AS HE REMOVED THE ROD, HE NOTICED THAT THE NECK OF THIS SCREW WAS BROKEN. HE TRIED TO REMOVE THIS SCREW SHAFT, HOWEVER, HE COULD NOT DO THAT. FINALLY, HE CLOSED AN INCISION WITH THE BROKEN SCREW SHAFT LEFT IN THE BONE. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY. THE SURGEON COMMENTS THAT IT DOES NOT MATTER IF THE BROKEN SCREW SHAFT IS LEFT IN THE BONE.
Patient problems: Device Embedded In Tissue or Plaque; Injury
MAUDE report 6912134 ↗
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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