VERTAPLEX HV SINGLE PACK
Received Feb 3, 2022 · Event occurred Jan 4, 2022
Report 0001811755-2022-00003 · MDR key 13446694
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Stryker Instruments-kalamazooModel number
0406622015Catalog number
0406622015
Lot number
VAB004
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS NOTED THAT THE SURGEON KNOWINGLY USED EXPIRED PRODUCT. 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. THIS REPORT IS ADDRESSING THE STERILITY RISK ASSOCIATED WITH SUCH AN EVENT.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. PRODUCT USED/IMPLEMENTED IN PATIENT.
Additional Manufacturer Narrative
E1: INITIAL REPORTER CONTACT DETAILS UPDATED. H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT RETURNED
Description of Event or Problem
IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS NOTED THAT THE SURGEON KNOWINGLY USED EXPIRED PRODUCT. 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. THIS REPORT IS ADDRESSING THE STERILITY RISK ASSOCIATED WITH SUCH AN EVENT.