OsteoMed 216-0302Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694004428), received between Dec 20, 2019 and Dec 20, 2019 — 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

Recent adverse event reports

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

• MalfunctionDec 20, 2019Patient Device Interaction Problem; Break; Material Protrusion/Extrusion; Patient Device Interaction Problem

  ON 12/15/2019 OATEOMED WAS NOTIFIED OF AN INCIDENT THAT OCCUR WITH OUR LOGIC, ACTIVATION WIRE, 62MM (PART NUMBER 216-03020). IT WAS BEING USED AS HALF OF A BI-LATERAL MANDIBLE DISTRACTION SURGERY. PER THE DISTRIBUTOR, THE PLATE WAS IMPLANTED ON (B)(6) 2019 AND 3 DAYS POST OPERATION THE PATIENT WAS DISCHARGED HOME IN AN ATTEMPT TO DISTRACT MANDIBLE 20+MM. FIVE (5) DAYS POST OPERATION THE PATIENT'S MOM INITIATED DISTRACTION WITH SUPPLIED TOOL. TWELVE (12) DAYS POST-OPERATION THE MOTHER PRESENTED TO DR. (B)(6) WITH BROKEN LEFT SIDED DISTRACTOR WITH 5-10MM STILL PROTRUDING FROM THE MOVING PLATE. DID NOT SNAP OFF AT THE JOINT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9507758 ↗