BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM
Received Jul 13, 2026
Report 0002242816-2026-00084 · MDR key 25798918
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
B3: THE DATE OF THE EVENT IS UNKNOWN. AS THE PATIENT STATED THEY WERE EXPERIENCING PAIN AND SWELLING DURING TREATMENT, THE EVENT DATE IS ESTIMATED AS JUNE OF 2026. B5: THE PATIENT CALLED AND ADVISED THAT THE PAIN LEVEL WAS A 5 OUT OF 10, THE EVENT IS NOW CONSIDERED NON-REPORTABLE. H6: ADDITIONAL PATIENT CODE 4577: SWELLING/EDEMA WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION CAN BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR TRENDS.
Description of Event or Problem
THE SALES REP ADVISED THAT THE PATIENT IS EXPERIENCING FOOT SWELLING AND CALF PAIN WHILE USING THE OPAK. THE PATIENT WAS CALLED TO OBTAIN MORE INFORMATION BUT A VOICEMAIL WAS LEFT. UPDATE: (B)(6) 26: CALLED THE PATIENT AT (B)(6) , HE ADVISED THAT HE EXPERIENCED FOOT SWELLING AND CALF PAIN WHILE USING THE OPAK. THE PAIN LEVEL IS A 5 OUT OF 10. HE DIDN'T CALL THE DOCTOR. HE STILL WEARS THE UNIT A COUPLE OF HOURS A DAY AND HE IS STILL EXPERIENCING PAIN. HE HAS AN APPOINTMENT TO SEE HIS PHYSICIAN ON MONDAY, WILL CALL BACK WITH AN UPDATE.