OsteoMed 211-2005-CHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694000017), received between Sep 25, 2023 and Sep 25, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 25, 2023Break; Break

  AN "ADVERSE EVENT REPORT" WAS RECEIVED FROM THE HEALTH AUTHORITY IN CHINA. PER THE ADVERSE EVENT REPORT, " ON (B)(6), 2019, THE PATIENT BEGAN USING THE CRANIOFACIAL PLATE FIXATION SYSTEM AT 18:29 FOR MULTIPLE INTRACRANIAL HEMATOMA REMOVAL, MENINGOCELE REPAIR, SKULL REPAIR, AND INTRACRANIAL ARTERIOVENOUS MALFORMATION RESECTION. DURING THE SURGERY, THE DOCTOR USES A SCREWDRIVER TO FIX TITANIUM NAILS AND PLATES TO THE SKULL; AT AROUND 21:35, IT WAS FOUND THAT THE TITANIUM NAIL WAS BROKEN. IMMEDIATELY, A GRINDING DRILL WAS USED TO GRIND OUT A SURROUNDING PIT ON THE NEARBY BONE AND TWO BROKEN NAILS WERE REMOVED BEFORE CONTINUING THE SURGERY; THE SURGERY ENDED AT 22:15 AND THE PATIENT HAD NO ADVERSE REACTIONS." THE EVENT WAS REPORTED TO HAVE OCCURRED IN (B)(6) 2019 BUT HAD NOT BEEN REPORTED TO OSTEOMED. TTHE SCREW NVOLVED IN THE INCIDENT WAS NOT PROVIDED FOR OUR INVESTIGATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808115 ↗