MalfunctionLOF
SPINE FUSION STIMULATOR SYSTEM
Received Nov 18, 2025
Report MW5179027 · MDR key 23596063
Device
Generic name
Stimulator, Bone Growth, Non-invasive
Manufacturer
Zimmer Biomet SpineModel number
BONE GROWTH STIMULATORProduct problems
- Device-Device Incompatibility
Patient
NA · Unknown
- Incontinence
- Incontinence
Narrative
Description of Event or Problem
THE REASON FOR CALL WAS PATIENT STATES THEY HAD A SPINAL SURGERY AT THE END OF JUNE AND THE HCP GAVE THEM A BONE GROWTH STIMULATOR TO USE FROM BIOMET. PATIENT STATES THEY STARTED HAVING INCONTINENCE PROBLEMS REALLY BAD A COUPLE MONTHS AGO AND REALIZED MAYBE THE TWO SIGNALS ARE HURTING EACH OTHER. THE PATIENT HAS HAD TO WEAR DIAPERS. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).