FITBONE SUBCUTANEOUS ENERGY RECEIVER
Received Jun 9, 2026
Report 2183449-2026-00024 · MDR key 25449602
Device
Generic name
Fitbone Subcutaneous Energy Receiver, Product Code: Hsb
Manufacturer
Orthofix SrlModel number
FITBONECatalog number
60001780
Product problems
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
RECEIVED INFORMATION THAT ALLEGED THE FITBONE RECEIVER, IMPLANTED ON (B)(6) 2026, DID NOT LENGTHEN. THE RECEIVER WAS IMPLANTED AND TESTED. AS PER THE REPORTER ONE WEEK POSTOPERATIVELY LENGTHENING WAS NOT WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE RECEIVER. NAIL IS LENGTHENING AS INTENDED AFTER RECEIVER REPLACEMENT.
Additional Manufacturer Narrative
DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR INVESTIGATION, BUT IT HAS BEEN REQUESTED TO RETURN. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE COMPLETED AND A FOLLOW-UP REPORT WILL BE SUBMITTED.