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MOUNTAINEER 188318416Recalls & reported problems

Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4 x 16mm · Class 2 · Implant

All models of MOUNTAINEER (51)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034157412), received between Nov 15, 2021 and Nov 15, 2021 — classified as 3 injuries.

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

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • Osteolysis3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CERVICAL-THORACIC POSTERIOR FUSION (C4-T2 EXCLUDING C7) FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL). ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH ADJACENT SEGMENT DISEASE (ASD) WHICH REQUIRED DECOMPRESSION FUSION BETWEEN T2 AND T3. ALL IMPLANTS FUSED IN 2011 HAD NO DEFECT SO THE FUSION WILL BE EXTENDED. THE REVISION OF C7, T3 (OR UP TO T4) WAS PLANNED FOR (B)(6) 2021. THIS REPORT IS FOR ONE (1) MINI POLYAXIAL BONE SCREW 3.5 X 4 X 16MM. THIS IS REPORT 8 OF 11 FOR (B)(4).

    Patient problems: Osteolysis

    MAUDE report 12814820 ↗
  • InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CERVICAL-THORACIC POSTERIOR FUSION (C4-T2 EXCLUDING C7) FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL). ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH ADJACENT SEGMENT DISEASE (ASD) WHICH REQUIRED DECOMPRESSION FUSION BETWEEN T2 AND T3. ALL IMPLANTS FUSED IN 2011 HAD NO DEFECT SO THE FUSION WILL BE EXTENDED. THE REVISION OF C7, T3 (OR UP TO T4) WAS PLANNED FOR (B)(6) 2021. THIS REPORT IS FOR ONE (1) MINI POLYAXIAL BONE SCREW 3.5 X 4 X 16MM. THIS IS REPORT 7 OF 11 FOR (B)(4).

    Patient problems: Osteolysis

    MAUDE report 12814785 ↗
  • InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CERVICAL-THORACIC POSTERIOR FUSION (C4-T2 EXCLUDING C7) FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL). ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH ADJACENT SEGMENT DISEASE (ASD) WHICH REQUIRED DECOMPRESSION FUSION BETWEEN T2 AND T3. ALL IMPLANTS FUSED IN 2011 HAD NO DEFECT SO THE FUSION WILL BE EXTENDED. THE REVISION OF C7, T3 (OR UP TO T4) WAS PLANNED FOR (B)(6) 2021. THIS REPORT IS FOR ONE (1) MINI POLYAXIAL BONE SCREW 3.5 X 4 X 16MM. THIS IS REPORT 6 OF 11 FOR (B)(4).

    Patient problems: Osteolysis

    MAUDE report 12814505 ↗

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Sources and updates

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