MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2019-10-02 for CAVUX CERVICAL CAGE-T PD-31-100 manufactured by Providence Medical Technology, Inc..
| Report Number | 3009394448-2019-00012 |
| MDR Report Key | 9146368 |
| Report Source | STUDY |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-20 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-07 |
| Date Added to Maude | 2019-10-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. JANIE MANDRUSOV |
| Manufacturer Street | 3875 HOPYARD RD SUITE 300 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 4153013128 |
| Manufacturer G1 | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 3875 HOPYARD RD SUITE 300 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVUX CERVICAL CAGE-T |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL |
| Product Code | ODP |
| Date Received | 2019-10-02 |
| Model Number | PD-31-100 |
| Catalog Number | PD-31-100 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 3875 HOPYARD RD SUITE 300 PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-02 |