ORTHOBLAST-II PASTE
Received Apr 13, 2015
Report 2090010-2015-00004 · MDR key 4691835
Device
Generic name
Orthoblast
Manufacturer
Isotis Orthobiologics, IncCatalog number
02-2100-010
Lot number
141899(SUSPECTED LOT)
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
THIS IS THE FOURTH OF 5 REPORTS FOR THIS PRODUCT PROBLEM (REF PT ID: (B)(6)). IT WAS REPORTED THAT FOLLOWING AN INTERBODY FUSION SURGERY THERE WAS INFECTION, PUS WAS FOUND. THE PRODUCT IS STILL IMPLANTED IN THE PT. IT WAS REPORTED THE CURRENT OPINION IS THE PROBLEM IS NOT BECAUSE OF THE ORTHOBLAST PRODUCT. THE INFECTED PTS ARE ALL ELDERLY, OVER 70 YEARS OLD, AND HAVE HAD COMBINED ORTHOPEDIC SURGERY (POSTEROLATERAL FUSION, INTERBODY FUSION WITH BONE SUBSTITUTE). ADD'L INFO HAS BEEN REQUESTED.
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE RETURNED SINCE IT REMAINS IMPLANTED. BASED ON REPORTED INFO, INTEGRA HAS INITIATED AN INVESTIGATION.