NDI PASSIVE SPHERES
Received Sep 5, 2025 · Event occurred Oct 5, 2023
Report 3002743211-2025-00066 · MDR key 22979769
Device
Generic name
N/a
Manufacturer
Ndi (northern Digital Inc.)Model number
8801075Catalog number
8801075
Lot number
2304101
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PATIENT CONSEQUENCES WERE NOT REPORTED WITH THE INITIAL REPORT.
Description of Event or Problem
(B)(6) 2023 (B)(6) (REP HCP FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO CLOSE THE SURGICAL INCISION, THE GREY PORTION OF THE NAVIGATION SPHERE CAME OFF IN THE DOME AND REMAINED IN THE OPERATIVE FIELD. WHEN THE INSTRUMENT WAS CHECKED THE NAVIGATOR SPHERE WAS FOUND WITH THE HALF GREY PORTION MISSING. THE DEVICE WAS FOUND AND DID NOT REMAIN IN THE PATIENT'S BODY.