MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-10-30 for TILOCK PEDICLE SCREW SYSTEM 1 GLC124-S manufactured by Genesys Spine.
| Report Number | 3008455034-2019-00010 |
| MDR Report Key | 9256708 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-10-02 |
| Date Mfgr Received | 2019-10-02 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2019-10-30 |
| 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 78746 |
| Manufacturer Country | US |
| Manufacturer Postal | 78746 |
| Manufacturer Phone | 5123817071 |
| 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 | 2019-10-30 |
| Model Number | 1 |
| Catalog Number | GLC124-S |
| Lot Number | AN20180515 |
| 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 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-30 |