UNKNOWN SMART TOE IMPLANT
Received Jul 17, 2020 · Event occurred Jan 1, 2014
Report 0008031020-2020-01923 · MDR key 10289212
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Adhesion(s)
- Scar Tissue
- Adhesion(s)
- Scar Tissue
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.
Description of Event or Problem
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY (B)(6) HOSPITAL, IN (B)(6). THE TITLE OF THIS REPORT IS ¿COMPARATIVE STUDY OF INTRAMEDULLARY HAMMERTOE FIXATION¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SMART TOE¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/29337598. WITHIN THAT PUBLICATION WHICH INCLUDED 54 PATIENTS, POST-OPERATIVE COMPLICATIONS WERE REPORTED, WHICH ALLEGEDLY OCCURRED FROM MARCH 2010 TO JANUARY 2014. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES (2) CASES OF ADHESIONS/SCAR TISSUE.