Bone Wax BW25GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521196261), received between Jun 22, 2017 and May 2, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE LITERATURE, PATIENT WHO INITIALLY UNDERWENT CRANIOTOMY FOR THE EVACUATION OF SUBDURAL HEMATOMA AND REPAIR OF DEPRESSED SKULL FRACTURE, BONE WAX WAS MIGRATED INTRACRANIALLY. POSTOPERATIVELY, PATIENT DEVELOPED SHORT-TERM MEMORY LOSS, APRAXIA, AND WORD FINDING DIFFICULTIES. THE IMAGING FINDINGS WERE CONSISTENT WITH THE PRESENCE OF A FOREIGN BODY CENTERED IN THE POSTERIOR ASPECT OF THE LEFT MIDDLE TEMPORAL GYRUS, WHICH WAS SURGICALLY REMOVED AND FOUND TO BE BONE WAX.

  Patient problems: Memory Loss/Impairment; No Code Available; Radiation Exposure, Unintended

  MAUDE report 8575833 ↗
• InjuryDec 18, 2017Device Operates Differently Than Expected

  DURING SURGERY, IT WAS REPORTED THAT THE PRODUCT HAD A BAD TEXTURE AND BAD SUPPORT IN THE BONE WITH DIFFICULT USE RESULTING TO AN ABSENCE OF HEMOSTATIC EFFECT. THERE WAS AN APPEARED OF A HEMATOMA AND ANOTHER SURGERY HAD BEEN NECESSARY TO RESOLVE THE CASE.

  Patient problems: Hematoma

  MAUDE report 7128153 ↗
• InjuryJun 22, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A BAD TEXTURE AND BAD SUPPORT IN THE BONE WITH DIFFICULT USE, RESULTING TO AN ABSENCE OF HAEMOSTATIC EFFECT. ANOTHER SURGERY HAD BEEN NECESSARY TO RESOLVE THE CASE. THE PATIENT IS ALIVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; No Code Available

  MAUDE report 6661905 ↗