MOUNTAINEER 188318318Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 18mm · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034157207), received between Jul 20, 2020 and Nov 2, 2020 — classified as 1 injury, 1 malfunction.
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
- Failure of Implant1
- Injury1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2020Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEVICE FOUND BROKEN AT THE DC. IT WAS UNKNOWN WHEN AND HOW IT WAS HAPPENED. THE PLASTIC BAG IS BROKEN WITH THE SAME SEAL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MNTR F/A SCREW 3.5X18. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10772941 ↗InjuryJul 20, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD A FALL AND FELL FACE FIRST RESULTING IN THE BREAKING OF MOUNTAINEER SCREWS AT C1 AND C2 MIDSHAFT. A REVISION SURGERY IS PENDING THE MRI AND CT RESULTS. CONCOMITANT DEVICES: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN OCCIPITAL PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 18MM. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: Failure of Implant; Injury
MAUDE report 10295952 ↗
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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