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PIPELINE 288205053Recalls & reported problems

Medos International Sàrl · PIPELINE ACCESS SYSTEM OSTEOTOME, ANGLED 8mm · Class 1

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 10705034220536), received between Apr 15, 2020 and Apr 15, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 15, 2020Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2020 THE 8MM OSTEOTOME ANGLED WAS FOUND TO BE BROKEN DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 8MM OSTEOTOME ANGLED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 9962361 ↗

Other OSTEOTOME devices

All OSTEOTOME devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.