FDA Adverse Event
Malfunction
Summary report: N
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 1442908
·
Received April 30, 2009
Report
- Report Number
- 1030489-2009-00401
- Event Type
- Malfunction
- Date Received
- April 30, 2009
- Report Date
- April 3, 2009
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- 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. THE SUSPECT DEVICES IN USE ARE LOT # H08H7107 AND # W07K3185. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 876-313, 510K # K970806 WAS CLEARED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WHO HAD THE DISC HERNIATION UNDERWENT A SPINAL PROCEDURE AT C3-C6 USING ANTERIOR FIXATION. IT WAS REPORTED THAT THE SCREW MIGHT HAVE BACKED OUT POST OP. NO REVISION SURGERY IS REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | BONE SCREW | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |