CERAMENT™BONE VOID FILLER A0210-08Recalls & reported problems
Bone Support AB · CERAMENT BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains Iohexol as a radio-contrast enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo. By combining hydroxyapatite and calcium sulfate a balance is achieved between implant resorption rate and bone in-growth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone in-growth and gives long term structural support to newly formed bone. The ceramic bone graft substitute is placed into the bone defect under visual inspection or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate the filling of the bone defect. When fully set in vivo, CERAMENT BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure. · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07350055430035), received between Jan 13, 2020 and Apr 26, 2024 — classified as 2 injuries, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Migration2
- Off-Label Use1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Infiltration into Tissue2
- Inflammation2
- Post Operative Wound Infection2
- Wound Dehiscence2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2024Off-Label Use; Device Dislodged or Dislocated; Migration; Off-Label Use; 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. ENTEROBACTER CLOACAE COMPLEX INFECTION DUE TO OPEN WOUND REQUIRING INFECTIOUS DISEASE CONSULT, IV FOLLOWED BY LONG TERM PO ANTIBIOTICS. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.
Patient problems: Infiltration into Tissue; Inflammation; Post Operative Wound Infection; Wound Dehiscence
MAUDE report 19189458 ↗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. INFECTION (MRSA) DUE TO OPEN WOUND REQUIRING LONG TERM ANTIBIOTICS. SIGNIFICANT DELAY IN PATIENT'S ABILITY TO RETURN TO ACTIVITY.
Patient problems: Infiltration into Tissue; Inflammation; Post Operative Wound Infection; Wound Dehiscence
MAUDE report 19189437 ↗MalfunctionJan 13, 2020Tear, Rip or Hole in Device Packaging
ACCORDING TO CUSTOMER THERE WAS A HOLE IN THE PACKAGE (TYVEK POUCH) WHICH WAS THE STERILE BARRIER. THE HOLE WAS DISCOVERED BEFORE USE OF THE DEVICE AND THE DEVICE WAS NEVER IMPLANTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION BUT WITHOUT THE TYVEK POUCH. THE INVESTIGATION WAS CLOSED BECAUSE LACK OF INFORMATION. NO OTHER COMPLAINTS HAVE BEEN REPORTED TO THE MANUFACTURER CONCERNING HOLE IN THE PACKAGE (TYVEK POUCH).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9580376 ↗
Other Filler, Bone Void, Calcium Compound devices
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44150Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42280Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- HydroSet XT 897003Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.