FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 2624704
·
Received December 11, 2009
Report
- Report Number
- 1030489-2009-01164
- Event Type
- Malfunction
- Date Received
- December 11, 2009
- Report Date
- November 19, 2009
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- UNK
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 806ECT, 510K # K991528 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
Description of Event or Problem · 1
MALFUNCTION OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | UNK | MEDTRONIC SOFAMOR DANEK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |