CERAMENT™BONE VOID FILLER A0210-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07350055430066), received between Jan 4, 2022 and Apr 26, 2024 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryApr 26, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  POST-OPERATIVELY THE INCISION HEALED NICELY THEN WEEKS LATER THE INCISION OPENED AND STARTED DRAINING LIQUID CERAMENT. ON SECOND OPERATION, ALL OF THE CERAMENT WITHIN THE CAVITY WAS LIQUID - NOT SOLID. RETURN TO OPERATING ROOM TO REMOVE CERAMENT AND RE-CLOSE THE INCISION. UNNECESSARY ANESTHESIA, COST OF RE-OPERATION. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.

  Patient problems: Infiltration into Tissue; Inflammation; Wound Dehiscence

  MAUDE report 19189466 ↗
• InjuryApr 26, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  POST-OPERATIVELY THE INCISION HEALED NICELY THEN WEEKS LATER THE INCISION OPENED AND STARTED DRAINING LIQUID CERAMENT. ON SECOND OPERATION, ALL OF THE CERAMENT WITHIN THE CAVITY WAS LIQUID - NOT SOLID. RETURN TO OPERATING ROOM TO REMOVE CERAMENT AND RE-CLOSE THE INCISION. UNNECESSARY ANESTHESIA, COST OF RE-OPERATION. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.

  Patient problems: Infiltration into Tissue; Inflammation; Wound Dehiscence

  MAUDE report 19189341 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION GIVEN BY REPORTING SURGEON IN INTERVIEW AND FOLLOW-UP OF INTERVIEW 2023-04-18: ON APRIL 10TH 2023 A MINIMALLY INVASIVE/ PERCUTANEOUS PROCEDURE WAS PERFORMED ON A 67 YEAR OLD MALE PATIENT WITH A DIAGNOSIS OF PLANTAR FASCIITIS AND CONCOMITANT BONE MARROW LESIONS VISIBLE ON PRE-OPERATIVE DIAGNOSTIC MRI SCAN WITHIN THE CALCANEUM. THE PROCEDURE INVOLVED ADDRESSING THE PLANTAR FASCIA SOFT TISSUE COMPONENT USING TENEX. THE BONY COMPONENT OF THE PROCEDURE WAS CARRIED OUT UNDER FLUOROSCOPIC GUIDANCE WITH A MINI-C-ARM AND BOTH AP AND LATERAL IMAGES WAS OBTAINED TO CONCLUDE THAT THE BONESUPPORT DELIVERY CANNULA USED FOR INJECTING THE CERAMENT BVF WAS INDEED IN THE CANCELLOUS BONE OF THE CALCANEUM. THE KIT USED WAS AN 18 CC (ML) VOLUME OF CERAMENT BVF OF WHICH 1.5-2 ML WAS FINALLY USED. IT WAS PROCEEDED TO FILL THE BONE MARROW LESIONS WITHOUT EXERTING TOO MUCH PRESSURE WHILST DOING SO. THERE WAS AN INITIAL RADIO-OPACIFICATION WITHIN THE CALCANEUM RELATED TO THE IOHEXOL COMPONENT OF THE PRODUCT BUT THEN IT BECAME EVIDENT ON FLUOROSCOPY THAT THIS SAME RADIO-OPAQUE MATERIAL WAS MIGRATING AND APPEARED TO HAVE TRACKED INTO A VEIN ON THE LATERAL SIDE. WHEN THIS PHENOMENON WAS RECOGNIZED

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16872521 ↗
• DeathJan 4, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER THE FOLLOWING OCCURRED: PATIENT UNDERGOING HIP REVISION EXPERIENCED CARDIAC COLLAPSE WITH DEATH FOLLOWING INJECTION OF CERAMENT BONE VOID FILLER. MICROSCOPIC AUTOPSY EXAMINATION CONCLUDE CAUSE OF DEATH AS EXTENSIVE PULMONARY MICRO-EMBOLI OF FOREIGN MATERIAL CONSISTENT WITH CERAMENT BONE VOID FILLER MATERIAL. NO FAT EMBOLI WERE IDENTIFIED.

  Patient problems: Asystole; Bradycardia

  MAUDE report 13153147 ↗