MOUNTAINEER 288306000Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM INSERTER X15 · Class 1
All models of MOUNTAINEER (51)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034221434), received between Jul 16, 2021 and Jul 16, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.
Most reported problems
Device problems
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2021Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREW HEADS WERE FRAYED. THERE WAS NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) X15 INSERTER SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12181728 ↗MalfunctionJul 16, 2021Material Twisted/Bent; Material Twisted/Bent
THIS REPORT IS FOR ONE (1) X15 INSERTER SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12181625 ↗
Other DRIVER, PROSTHESIS devices
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- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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