MalfunctionORR
INSTRUMENT, STEREOTAXIC
Received May 15, 2019 · Event occurred Jul 6, 2017
Report 1723170-2019-02362 · MDR key 8611337
Device
Generic name
Instrument, Stereotaxic
Manufacturer
Medtronic Navigation, IncModel number
9734056Catalog number
9734056
Product problems
- Imprecision
- Imprecision
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE'S CROSS HAIR STATIONARY WAS USED, BUT PROBE IN THE TRAJECTORY WAS SHOWN OBLIQUELY. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION WITH NO PATIENT INJURY. IT OCCURRED INTRA/PERI-OPERATIVELY WITH NO DELAY TO SURGICAL TIME.