VERTAPLEX HV SINGLE PACK
Received May 7, 2022 · Event occurred Apr 9, 2022
Report 0001811755-2022-00017 · MDR key 14322672
Device
Generic name
Cement, Bone, Vertebroplasty
Manufacturer
Stryker Instruments-kalamazooModel number
0406622015Catalog number
0406622015
Lot number
VKC069
Product problems
- Improper Flow or Infusion
- Thickening of Material
- Improper Flow or Infusion
- Thickening of Material
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED BY CUSTOMER.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CEMENT VISCOSITY WAS TOO HIGH AND CAUSED THE DELIVERY CANNULA TO GET STUCK IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A DELAY LEADING TO PROLONGED SURGICAL TIME AND LONGER TIME UNDER ANESTHESIA FOR THE PATIENT. IT WAS ALSO REPORTED THAT THE SURGEON PERFORMED A SPONDYLODESIS (SPINAL FUSION) TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT A PART OF THE GUIDE SLEEVE REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CEMENT VISCOSITY WAS TOO HIGH AND CAUSED THE DELIVERY CANNULA TO GET STUCK IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A DELAY LEADING TO PROLONGED SURGICAL TIME AND LONGER TIME UNDER ANESTHESIA FOR THE PATIENT. IT WAS ALSO REPORTED THAT THE SURGEON PERFORMED A SPONDYLODESIS(SPINAL FUSION) TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT A PART OF THE GUIDE SLEEVE REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR RETURN.