BIOPRO GO-EZ SCREW
Received Jun 25, 2014 · Event occurred May 16, 2014
Report 1833506-2014-00002 · MDR key 3934640
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COMPONENT WAS IMPLANTED AFTER STERILE EXPIRATION DATE. EXPIRATION DATE WAS 12-2013. COMPONENT WAS IMPLANTED ON (B)(6) 2014. FACILITY WAS AWARE OF THIS AND IMPLANTED IT ANYWAY.
Additional Manufacturer Narrative
CURRENT STERILE VALIDATION COVERS A (B)(4) PERIOD FOR BLISTERS WITH TYVEK LIDS. PRODUCT WAS IMPLANTED 2 WEEKS AFTER THE VALIDATION WINDOW. BIOPRO PRODUCT PACKAGED WITH (B)(4) HAS BEEN VALIDATED TO (B)(4). TESTING/VALIDATION IS BEING PERFORMED AT THIS TIME TO EXTEND THE STERILITY DATE ON THE BLISTERS. FACILITY FAILED TO HEED THE STERILE EXPIRATION DATE ON THE PRODUCT BOX. AT THIS TIME THE PATIENT HAS HAD NO PROBLEMS.