MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-12 for VARILIFT LX CIE3-11-24-00 manufactured by Wenzel Spine, Inc..
| Report Number | 3008009850-2020-00002 |
| MDR Report Key | 9826049 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-25 |
| Device Manufacturer Date | 2018-07-11 |
| Date Added to Maude | 2020-03-12 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARILIFT LX |
| Generic Name | LUMBAR INTERBODY FUSION DEVICE |
| Product Code | MAX |
| Date Received | 2020-03-12 |
| Catalog Number | CIE3-11-24-00 |
| Lot Number | BB008A |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WENZEL SPINE, INC. |
| Manufacturer Address | 1130 RUTHERFORD LANE 200 AUSTIN, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |