InjuryPBF
PARAGON
Received Jun 12, 2026 · Event occurred Jun 6, 2026
Report 9614209-2026-00069 · MDR key 25481213
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
71 YR · Male
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION TO PERFORM INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
REVISION DUE TO BONE FRACTURE CAUSED BY PATIENT FALL.