MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-05 for PIVOX? OBLIQUE LATERAL SPINAL SYSTEM 2140020 manufactured by Medtronic Sofamor Danek Usa, Inc.
| Report Number | 1030489-2019-01268 |
| MDR Report Key | 9277031 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-05 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-10-07 |
| Device Manufacturer Date | 2016-07-16 |
| Date Added to Maude | 2019-11-05 |
| 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 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIVOX? OBLIQUE LATERAL SPINAL SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2019-11-05 |
| Model Number | NA |
| Catalog Number | 2140020 |
| Lot Number | NM16E087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-05 |