ORTHOBLAST-II PASTE
Received Oct 14, 2013
Report 2090010-2013-00015 · MDR key 3416178
Device
Generic name
Orthoblast
Manufacturer
Isotis Orthobiologics, IncCatalog number
02-2100-080
Lot number
071140
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
IT WAS REPORTED THE PT UNDERWENT SURGERY N (B)(6) 2008 FOR A REMOVAL OF A TUMOR IN THE BALL OF THE RIGHT FOOT. ORTHOBLAST PASTE WAS IMPLANTED. DURING SURGERY AS A "BONE VOID FILLER". ON A RECENT UNK DATE, THE PT REPORTEDLY "BECAME ILL WITH SYMPTOMS OF AN ALLERGIC REACTION". BLOOD WORK WAS OBTAINED WHICH DETERMINED THE PT WAS ALLERGIC TO COBALT CHLORIDE. THE PT IS CURRENTLY BEING TREATED BY A PRIMARY CARE PHYSICIAN FOR THE CURRENT ALLERGIC REACTION SYMPTOMS.
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.