MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-26 for KYOCERA TESERA SC STAND ALONE CERVICAL CAGE S 150 1055-161-307 manufactured by Kyocera Medical Technologies, Inc.
| Report Number | 3015398319-2019-00001 |
| MDR Report Key | 9379327 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2016-04-22 |
| Date Added to Maude | 2019-11-26 |
| 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 | MRS. RACHELLE HEMINGER |
| Manufacturer Street | 1200 CALIFORNIA ST. SUITE 210 |
| Manufacturer City | REDLANDS CA 92374 |
| Manufacturer Country | US |
| Manufacturer Postal | 92374 |
| Manufacturer Phone | 9095572360 |
| Manufacturer G1 | KYOCERA MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Street | 1200 CALIFORNIA ST. SUITE 210 |
| Manufacturer City | REDLANDS CA 92374 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYOCERA TESERA SC STAND ALONE CERVICAL CAGE |
| Generic Name | SA CERVICAL CAGE |
| Product Code | OVE |
| Date Received | 2019-11-26 |
| Model Number | S 150 |
| Catalog Number | 1055-161-307 |
| Lot Number | 3296-9 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYOCERA MEDICAL TECHNOLOGIES, INC |
| Manufacturer Address | 1200 CALIFORNIA ST. SUITE 210 REDLANDS CA 92374 US 92374 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-26 |