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MOUNTAINEER 188311302Recalls & reported problems

Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM ADJUSTABLE WEDDING BAND 3.5 - 5.5mm · Class 2 · Implant

All models of MOUNTAINEER (51)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034156774), received between Nov 29, 2017 and Nov 19, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Device Dislodged or Dislocated1
  • Manufacturing, Packaging or Shipping Problem1
  • Separation Problem1

Patient problems

  • Not Applicable3
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE IMPLANT ADJUST WEDDING BAND CAME APART. THERE WAS A ONE (1) TO TWO (2) MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ADDITIONAL IMPLANTS. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK ¿ PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12845889 ↗
  • MalfunctionSep 4, 2018Separation Problem; Separation Problem

    IT WAS REPORTED MOUNTAINEER PART # 1883-11-302- ADJUSTABLE 3.5/5.5 SIDE BY SIDE ROD CONNECTOR-WEDDING BAND FAILED WHEN THE ¿FLANGE¿ PULLED THROUGH AND PARTIALLY SEPARATED FROM EACH SIDE OF THE IMPLANT. ONLY ONE OF THIS PART NUMBER FAILED, AND WAS REPLACED WITHIN 10 MINUTES.

    Patient problems: Not Applicable

    MAUDE report 7842167 ↗
  • MalfunctionJan 7, 2018Manufacturing, Packaging or Shipping Problem

    ON (B)(6) 2017 AT 6:30PM, SURGEON DECLARED THAT IMPLANT FAILED DUE TO "FLANGE" DESIGN.

    Patient problems: Not Applicable

    MAUDE report 7170694 ↗
  • MalfunctionNov 29, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE MOUNTAINEER SYSTEM. THE FIXED AREA WAS C2 ¿ T4. DURING THE SURGERY, THE FOLLOWING IMPLANT GOT BROKEN WHEN THE SURGEON TRIED TO PLACE IT IN THE BODY. MNTR ADJUST WEDDING BAND 3.5-5.5 (PART#: 188311302, LOT#: CA5BL94). THE SURGEON DEALT WITH THIS EVENT BY USING A SPARE IMPLANT. NO BROKEN PARTS WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS COMPLETED WITH A 2-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient; Not Applicable

    MAUDE report 7069444 ↗

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Sources and updates

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