ORTHOBLAST-II PASTE
Received Jun 2, 2015
Report 2090010-2015-00007 · MDR key 4817734
Device
Product problems
- Device Expiration Issue
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE RETURNED SINCE IT REMAINS IMPLANTED. BASED ON REPORTED INFORMATION, INTEGRA HAS INITIATED AN INVESTIGATION.
Additional Manufacturer Narrative
INFORMATION OMITTED FROM INITIAL REPORT IN ERROR. THE PRODUCT WAS NOT EXPLANTED. INTEGRA HAS COMPLETED THE INTERNAL INVESTIGATION ON 06/11/2015. THE ADDITIONAL INVESTIGATION ACTIVITIES INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINT HISTORY. RESULTS: ORTHOBLAST II PASTE PRODUCT WAS MANUFACTURED UNDER LOT NUMBER 130608. THE COMPLETE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. THE PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE PRODUCT IS TERMINALLY STERILIZED ACCORDING TO REQUIRED SPECIFICATIONS. WHEN USED PRIOR TO THE EXPIRATION DATE, THE PROBABILITY OF HAVING CONTAMINATION IS ONE IN ONE-MILLION. THE COMPLAINT DATABASE WAS REVIEWED FOR THE LAST TWO YEARS AND THERE WERE NO RELATED INCIDENTS FOR THIS PRODUCT OR ISSUE. CONCLUSION: THE PRODUCT WAS USED "OFF LABEL".
Description of Event or Problem
IT WAS REPORTED THE SURGEON IMPLANTED A "PASTE" PRODUCT, HOWEVER, AFTERWARD HE NOTICED THAT THE PRODUCT WAS EXPIRED BY 2 DAYS. NO PATIENT IMPACT WAS INDICATED.