MalfunctionMBB
SIMPLEX P SPEEDSET CEMENT
Received May 24, 2021 · Event occurred Apr 28, 2021
Report 11869568 · MDR key 11869568
Device
Generic name
Bone Cement, Antibiotic
Manufacturer
Stryker Howmedica Osteonics Corp.Catalog number
6192-1-001
Product problems
- Output Problem
- Material Too Soft/Flexible
Patient
27010 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
SIMPLEX P SPEEDSET NOT HARDENING AFTER BEING IMPLANTED FOR 14 MINUTES. CEMENT PEDAL UTILIZED, WITH CEMENT MIXED FOR 1 MIN 30 SECONDS. THE OR SUITE AT 64 DEGREES. CEMENT HARDENED AFTER 15 MINUTES. SAVED THE PRODUCT INFORMATION FOR COORDINATOR.
Description of Event or Problem
SIMPLEX P SPEEDSET NOT HARDENING AFTER BEING IMPLANTED FOR 14 MINUTES. CEMENT PEDAL UTILIZED, WITH CEMENT MIXED FOR 1 MIN 30 SECONDS. THE OR SUITE AT 64 DEGREES. CEMENT HARDENED AFTER 15 MINUTES. SAVED THE PRODUCT INFORMATION FOR COORDINATOR.