ORTHOBLAST-II PASTE
Received Apr 10, 2015
Report 2090010-2015-00001 · MDR key 4687106
Device
Generic name
Orthoblast
Manufacturer
Isotis Orthobiologics, IncCatalog number
02-2100-010
Lot number
141899 (SUSPECTED LOT)
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Purulent Discharge
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE PRODUCT WILL NOT RETURNED SINCE IT REMAINS IMPLANTED. BASED ON REPORTED INFORMATION, INTEGRA HAS INITIATED AN INVESTIGATION.
Description of Event or Problem
THIS IS THE FIRST OF 5 REPORTS FOR THIS PRODUCT PROBLEM (REF PATIENT 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 PATIENT. IT WAS REPORTED THE CURRENT OPINION IS THE PROBLEM IS NOT BECAUSE OF THE ORTHOBLAST PRODUCT. THE INFECTED PATIENTS ARE ALL ELDERLY, OVER 70 YEARS OLD, AND HAVE HAD COMBINED ORTHOPEDIC SURGERY (POSTEROLATERAL FUSION, INTERBODY FUSION WITH BONE SUBSTITUTE). ADDITIONAL INFORMATION HAS BEEN REQUESTED.