MalfunctionLOF

BONE STIMULATOR

Received Apr 1, 2026

Report MW5186285 · MDR key 24764436

Device

Generic name

Stimulator, Bone Growth, Non-invasive

Manufacturer

Unknown

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: IT WAS REPORTED THE PATIENT TRIED TURNING ON THEIR BONE STIMULATOR AND NOTICED THE CHARGING CABLE HAS WIRES EXPOSED/SHOWING AND IT IS NOT WORKING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).