VERTAPLEX HV GLOBAL TWIN PK
Received Aug 12, 2022 · Event occurred Jul 14, 2022
Report 0001811755-2022-00031 · MDR key 15218505
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Stryker Instruments-kalamazooCatalog number
0406622000
Lot number
VKA067
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
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING RETURN OF DEVICE TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AND UPON RECEIPT, THE CEMENT PRODUCT WAS OBSERVED TO BE EXPIRED. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
CORRECTION FROM REPORTABLE EVENT TO NON REPORTABLE EVENT; THE REPORTED EVENT, FOR EXPIRED CEMENT, WAS NOT CONFIRMED AS FOLLOWING A REVIEW OF THE DEVICE HISTORY INFORMATION VERSUS THE REPORTED EVENT DATE OF THIS EVENT THE PRODUCT HAD NOT EXPIRED AT THE TIME OF USE. NO PRODUCT MALFUNCTION WAS OBSERVED FOLLOWING A REVIEW OF MANUFACTURING EXPIRY INFORMATION AND EVENT DETAILS REPORTED IN THIS CASE. THE CEMENT WAS NOT EXPIRED AT THE TIME OF USE. BASED ON THE INFORMATION PROVIDED, THERE IS NO REPORT OF ADVERSE CONSEQUENCES, PATIENT INVOLVEMENT OR A SIGNIFICANT DELAY IN THIS EVENT. THERE IS NO REPORT OF ADVERSE CONSEQUENCES OR A SIGNIFICANT DELAY IN THIS EVENT AND NO PREVIOUS REPORTS OF INJURY ON FILE AS A RESULT OF SIMILAR EVENTS. HAVING REVIEWED THE RISK DOCUMENTATION, THERE IS NO INFORMATION TO SUGGEST THAT A RECURRENCE WOULD RESULT IN INJURY. THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST FILING IS NECESSARY. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS WILL BE RE-ASSESSED. H3 OTHER TEXT : DEVICE DISCARDED BY CUSTOMER.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AND UPON RECEIPT, THE CEMENT PRODUCT WAS OBSERVED TO BE EXPIRED. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. UPDATE (B)(6) 2023; FOLLOWING A REVIEW OF THE DEVICE HISTORY INFORMATION VERSUS THE REPORTED EVENT DATE OF THIS EVENT THE PRODUCT HAD NOT EXPIRED AT THE TIME OF USE. NO PRODUCT MALFUNCTION WAS OBSERVED FOLLOWING A REVIEW OF MANUFACTURING EXPIRY INFORMATION AND EVENT DETAILS REPORTED IN THIS CASE. THE CEMENT WAS NOT EXPIRED AT THE TIME OF USE. BASED ON THE INFORMATION PROVIDED, THERE IS NO REPORT OF ADVERSE CONSEQUENCES, PATIENT INVOLVEMENT OR A SIGNIFICANT DELAY IN THIS EVENT.