BIOMET EBI BONE HEALING SYSTEM
Received May 29, 2026
Report 0002242816-2026-00068 · MDR key 25334517
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THEIR FRACTURE SITE WHEN DURING TREATMENT WITH THE DEVICE. IT WAS LATER REPORTED THAT AFTER CONDUCTING A TIME TEST, THE PATIENT CONTINUED TO EXPERIENCE PAIN. THE PATIENT STATED THAT THE PAIN STARTS ABOUT AFTER 2 HOURS OF TREATMENT AND RATED THE PAIN LEVEL A 5 OUT OF 10. THE PATIENT STATED THAT AT APPROXIMATELY 3 HOURS OF TREATMENT, THE PAIN BECOMES UNBEARABLE AND INCREASES TO A 10 OUT OF 10. AT THIS POINT THE PATIENT REMOVES THE DEVICE. THE PATIENT STATED THAT THE PAIN IS ONLY AT THE FRACTURE SITE, THERE IS NO REDNESS OR SWELLING IN THE AREA. THE PATIENT DISCUSSED THE ISSUE WITH THEIR DOCTOR BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WILL CONTINUE TREATMENT AND LIMIT TREATMENT PERIODS TO 3 HOURS. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
SECTION B3: AS THE DATE OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS MAY OF 2026. D4: THE LOT NUMBER OF THE DEVICE IS UNKNOWN H4: AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN, THE DATE OF MANUFACTURE COULD NOT BE DETERMINED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.