UNKNOWN INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II
Received Sep 4, 2024 · Event occurred Sep 1, 2023
Report 0008031020-2024-00456 · MDR key 20137339
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Implant Pain
- Implant Pain
Narrative
Description of Event or Problem
THE PRESENT POST-MARKET CLINICAL FOLLOW-UP (PMCF) NAMED "POST-MARKET CLINICAL FOLLOW-UP OF STRYKER TRAUMA & EXTREMITY DEVICES: RETROSPECTIVE COHORT STUDY UTILIZING A US HEALTHCARE DATABASE: SAFETY AND PERFORMANCE OF THE SMART TOE II IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" WAS INTENDED TO PROVIDE ADDITIONAL CLINICAL DATA FROM THE REAL-WORLD USAGE OF SMART TOE II IMPLANTS. THE STUDY IS DESIGNED AS A PMCF ACTIVITY THAT WILL PROVIDE PERFORMANCE AND SAFETY DATA ON SMART TOE II IMPLANTS IN A REPRESENTATIVE POPULATION IN THE US. DURING THE REVIEW OF THE PMCF, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED : PAIN, GENERALIZED JOINT OR ANATOMIC REGION IN 33 CASES. THIS IS PATIENT # 25 OUT OF 33.
Additional Manufacturer Narrative
THE REPORTED EVENT PAIN, GENERALIZED JOINT OR ANATOMIC REGION COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.