FDA Adverse Event
Other
Summary report: N
CD HORIZON ADANTA
MDR report key: 1416585
·
Received April 3, 2009
Report
- Report Number
- 1030489-2009-00328
- Event Type
- Other
- Date Received
- April 3, 2009
- Date of Event
- March 5, 2009
- Report Date
- March 5, 2009
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # H08G6068, H08J8439, H08J8444, OR H08K8531. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540020, 510K # K052187 WAS CLEARED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE FOR SPONDYLOLISTHESIS AT L3/4/5 USING POSTERIOR FIXATION. ONE OF THE BREAK-OFF SET SCREWS COULD NOT BE BROKEN OFF AT LEFT SIDE L5 BECAUSE THE IMPLANTED ROD WAS TOO SHORT. THE SET SCREW WAS IMPLANTED IN THE PATIENT WITH THE TAB STILL INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON ADANTA | SET SCREW | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |