MalfunctionPML
UNKNOWN_INSTRUMENTS_PRODUCT
Received Jan 5, 2024 · Event occurred Nov 1, 2023
Report 3015967359-2024-00008 · MDR key 18454891
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
UNK_INS
Product problems
- Expiration Date Error
- Expiration Date Error
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 : PRODUCT USED/IMPLANTED IN PATIENT.
Description of Event or Problem
IT WAS REPORTED THE DAY AFTER SURGERY, BY THE HOSPITALS¿ BILLING DEPARTMENT THAT AN EXPIRED KIT OF CEMENT WAS USED DURING SURGERY. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.