inforMED
InjuryLOF

BIOMET EBI BONE HEALING SYSTEM

Received Jan 6, 2026

Report 0002242816-2026-00159 · MDR key 23977665

Device

Generic name

Stimulator, Bone Growth, Non-invasive

Manufacturer

Ebi, Llc.

Model number

1068234

Catalog number

1068234

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Pain

Narrative

Additional Manufacturer Narrative

SECTION B3: AS THE DATE OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS 2025. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAS PAIN WHEN WEARING THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.