MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-18 for TILOCK PEDICLE SCREW SYSTEM SEE EVALUATION SUMMARY manufactured by Genesys Spine.
| Report Number | 3008455034-2020-00001 |
| MDR Report Key | 9720688 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-05-02 |
| Date Added to Maude | 2020-02-18 |
| 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 | MR. ANDREW DAVISON |
| Manufacturer Street | 1250 S. CAPITAL OF TEXAS HWY BUILDING 3, SUITE 600 |
| Manufacturer City | AUSTIN, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 3817070 |
| Manufacturer G1 | GENESYS SPINE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TILOCK PEDICLE SCREW SYSTEM |
| Generic Name | ORTHOSIS, SPINAL PEDICLE FIXATION |
| Product Code | MNI |
| Date Received | 2020-02-18 |
| Model Number | SEE EVALUATION SUMMARY |
| Catalog Number | SEE EVALUATION SUMMARY |
| Lot Number | SEE EVALUATION SUMMARY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENESYS SPINE |
| Manufacturer Address | 1250 S. CAPITAL OF TEXAS HWY BUILDING 3, SUITE 600 AUSTIN, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |