BIOSTIM
Received Sep 18, 2025 · Event occurred Sep 3, 2025
Report 2183449-2025-00028 · MDR key 23086490
Device
Generic name
Osteogenesis Stimulator, Cervical-stim
Manufacturer
Orthofix, LlcModel number
655505-0001Catalog number
5505
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
67 YR · Female
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
DEVICE HAS NOT YET RETURNED FOR INVESTIGATION. WHEN THE DEVICE BECOMES AVAILABLE AN INVESTIGATION WILL BE PERFORMED AT THAT TIME. A REVIEW OF THE DHR WAS PERFORMED - ALL 60 UNITS FROM THIS WORK ORDER PASSED FINAL INSPECTION.
Description of Event or Problem
PATIENT CALLED AND REPORTED A 4X4 BURN ON THE BACK OF HER NECK. PATIENT STATED SHE DID NOT FEEL ANY HEAT COMING OFF OF THE DEVICE.
Description of Event or Problem
PATIENT CALLED AND REPORTED A 4X4 BURN ON THE BACK OF HER NECK. PATIENT STATED SHE DID NOT FEEL ANY HEAT COMING OFF OF THE DEVICE.
Additional Manufacturer Narrative
THE POWER SUPPLY DID NOT RETURN FOR INVESTIGATION BUT THE DEVICE WAS RETURNED. AS RECEIVED, DEVICE WAS ABLE TO POWER ON AND CHARGING AND PASS POST. AFTER FULLY CHARGED, DEVICE COMPLETED 4 HRS HEATING TEST. NO DAMAGE NOTED TO SYSTEM. SYSTEM OPERATES AS DESIGNED. PATIENT CALLED (B)(6) 2025 AND REPORTED THEY CONTINUE TO TREAT WITH THE DEVICE AND ARE DOING WELL. A REVIEW OF THE DHR WAS PERFORMED - ALL 60 UNITS FROM THIS WORK ORDER PASSED FINAL INSPECTION.