MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-11-03 for VERTE-STACK SPINAL SYSTEM * manufactured by Safamor-danek Deggendorf Gmbh.
| Report Number | 1030489-2006-00309 |
| MDR Report Key | 782745 |
| Report Source | 05 |
| Date Received | 2006-11-03 |
| Date Mfgr Received | 2006-10-11 |
| Date Added to Maude | 2006-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRSITINE SCIFERT, MS |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Street | WERTSTRASSE 17 |
| Manufacturer City | DEGGENDORF 94469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 94469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTE-STACK SPINAL SYSTEM |
| Generic Name | INTERBODY SPACER |
| Product Code | LYQ |
| Date Received | 2006-11-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 770544 |
| Manufacturer | SAFAMOR-DANEK DEGGENDORF GMBH |
| Manufacturer Address | WERTSTRASSE 17 DEGGENDORF GM 94469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-03 |