MalfunctionNDP
BioHorizons Internal Custom Cast Abutment
Received Jul 31, 2026
Report 1060818-2026-25536 · MDR key 50104743
Device
Generic name
Internal 4.5mm Custom Cast Abutment, Hexed
Manufacturer
Biohorizons Implant SystemsModel number
PGCAHCatalog number
PGCAH
Product problems
- Fracture
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
This report covers two (2) malfunction event. A review of the event involved the device(s) becoming fractured. No patient adverse event was reported. No information regarding patient demographics were provided.