InjuryLOF
OSTEOGENESIS STIMULATOR, CERVICAL-STIM
Received Jun 26, 2026 · Event occurred Jun 10, 2026
Report 2183449-2026-00026 · MDR key 25638796
Device
Generic name
Osteogenesis Stimulator, Cervical-stim
Manufacturer
Orthofix, LlcModel number
5505Catalog number
655505-0001
Product problems
- Insufficient Device Problem Information
Patient
69 YR · Unknown
- Rash
Narrative
Additional Manufacturer Narrative
DEVICE DID NOT RETURN FOR INVESTIGATION. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE PERFORMED AT THAT TIME. A REVIEW OF THE DHR WAS PERFORMED. ALL UNITS FROM THE WORK ORDER PASSED FINAL INSPECTION.
Description of Event or Problem
AS REPORTED THE PATIENT HAD A RASH ON THE LEFT SIDE OF THEIR CLAVICLE WHICH STARTED A MONTH AFTER USING THE DEVICE AND IS NOT GOING AWAY.