UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Apr 26, 2022 · Event occurred Mar 29, 2022
Report 0001811755-2022-00015 · MDR key 14210567
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
UNK_ICO
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Paralysis
- Paralysis
Narrative
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE, THE PATIENT WOKE UP AND WAS TEMPORARILY PARALYZED. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE, THE PATIENT WOKE UP AND WAS TEMPORARILY PARALYZED. NO FURTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE STRYKER CEMENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENTS TEMPORARY PARALYSIS. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MALFUNCTION EXPERIENCED WITH THE CEMENT.
Additional Manufacturer Narrative
H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR RETURN.