FDA Adverse Event
Malfunction
Summary report: N
INSTRUMENT, STEREOTAXIC
MDR report key: 8611337
·
Received May 15, 2019
Report
- Report Number
- 1723170-2019-02362
- Event Type
- Malfunction
- Date Received
- May 15, 2019
- Date of Event
- July 6, 2017
- Report Date
- May 15, 2019
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- ORR
- PMA / PMN Number
- K131425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403967 | INSTRUMENT, STEREOTAXIC | ORR | MEDTRONIC NAVIGATION, INC | 9734056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |