FDA Adverse Event
Malfunction
Summary report: N
ACC 961-580 SURETRAK2, LARGE CLAMP
MDR report key: 8812112
·
Received July 22, 2019
Report
- Report Number
- 1723170-2019-04166
- Event Type
- Malfunction
- Date Received
- July 22, 2019
- Date of Event
- June 27, 2019
- Report Date
- October 1, 2019
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- OLO
- PMA / PMN Number
- K983670
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO PARTS WERE RETURNED FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE CLAMP WAS RETURNED FOR ANALYSIS. FUNCTIONAL TESTING DETERMINED THAT THE CLAMP WAS MALFUNCTIONING CAUSING THE REPORTED ISSUE. 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 DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR. IT WAS REPORTED THAT THE SCREW ON THE SURETRAK WAS STRIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 605186 | ACC 961-580 SURETRAK2, LARGE CLAMP | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | MEDTRONIC NAVIGATION, INC | 961-580 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |