QRRClass IIImplant
Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Orthopedic · 21 CFR 888.3046
A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.
MDR events7All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances2All time
Recent MDR events
7 adverse event reports on file
- CERAMENT GMar 2, 2026InjuryBoneusupport Ab3005304945-2026-00002
- CERAMENT GFeb 13, 2026InjuryBoneusupport Ab3005304945-2026-00001
- CERAMENT GJan 20, 2026InjuryBone Support AbMW5182486
- CERAMENT GDec 10, 2025MalfunctionBoneusupport Ab3005304945-2025-00006
- CERAMENT GNov 6, 2025MalfunctionBoneusupport Ab3005304945-2025-00005
- CERAMENT GNov 5, 2025MalfunctionBoneusupport Ab3005304945-2025-00004
- CERAMENT GOct 11, 2023InjuryBonesupport Ab3005304945-2023-00002
Event type breakdown
Injury4
Malfunction3
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Device Difficult to Setup or Prepare2
Adverse Event Without Identified Device or Use Problem1
Device Contaminated at the User Facility1
Improper or Incorrect Procedure or Method1
Insufficient Device Problem Information1
Migration1
No Apparent Adverse Event1
Prophylactic removal due to corrective action1
Trend for “Device Difficult to Setup or Prepare”
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
2 clearances for this product code