VERTAPLEX HV SINGLE PACK
Received Nov 30, 2021 · Event occurred Nov 3, 2021
Report 0001811755-2021-00809 · MDR key 12893752
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Stryker Instruments-kalamazooModel number
0406622015Catalog number
0406622015
Lot number
UNKNOWN
Product problems
- Migration
- Migration
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT RETURNED
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT EXTRAVASATION OF CEMENT OCCURRED. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT EXTRAVASATION OF CEMENT OCCURRED. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED BY CUSTOMER.