UNKNOWN_INSTRUMENTS_PRODUCT
Received Jun 17, 2022 · Event occurred May 24, 2022
Report 3015967359-2022-01179 · MDR key 14734147
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
UNK_INS
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.
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 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.