FDA Adverse Event
Malfunction
Summary report: N
AWL TACTILE
MDR report key: 3165387
·
Received June 12, 2013
Report
- Report Number
- 1723170-2013-00432
- Event Type
- Malfunction
- Date Received
- June 12, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 16, 2013
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
RMA ISSUED. REPLACEMENT TACTILE AWL SHIPPED TO SITE (B)(4) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT, AS REPORTED, THE TIP OF THE INSTRUMENT IS VISIBLY BENT. PHYSICAL DAMAGE/DEFORMATION DIRECTLY CAUSED THE EVENT.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A LUMBAR FUSION PROCEDURE, THE SURGEON BENT THE TACTILE AWL AT THE S2 LEVEL. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF A DIFFERENT PROBE AND THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267144 | AWL TACTILE | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | 111221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |