inforMED
InjuryLOF

BIOMET EBI BONE HEALING SYSTEM

Received Jul 20, 2026

Report 0002242816-2026-00087 · MDR key 25874192

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 · Male

  • Pain

Narrative

Description of Event or Problem

THE PATIENT REPORTED EXPERIENCING PAIN AFTER 6 HOURS OF TREATMENT. THE PATIENT WAS ADVISED TO DO A TIME TEST, STARTING AT 5 HOURS FOR 2 DAYS. NO FURTHER CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

A: PATIENT INFORMATION: THE DATE OF BIRTH AND AGE OF THE PATIENT ARE UNKNOWN. B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS JUNE 2026. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. 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.