UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Apr 12, 2022 · Event occurred Mar 16, 2022
Report 3015967359-2022-00637 · MDR key 14087589
Device
Generic name
Cement, Bone, Vertebroplasty
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
UNK_ICO
Product problems
- Expiration Date Error
- Expiration Date Error
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER HAD USED AN EXPIRED PRODUCT DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE CUSTOMER ONLY REALIZED THIS AFTER IT WAS USED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER HAD USED AN EXPIRED PRODUCT DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE CUSTOMER ONLY REALIZED THIS AFTER IT WAS USED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.