MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-27 for ENDOSKELETON? TCS 5302-3516 manufactured by Titan Spine.
| Report Number | 3006340236-2020-00001 |
| MDR Report Key | 9765123 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-08-21 |
| Date Added to Maude | 2020-02-27 |
| 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 | TITAN SPINE |
| Manufacturer Street | 6140 W. EXECUTIVE DR. SUITE A |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSKELETON? TCS |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL |
| Product Code | OVE |
| Date Received | 2020-02-27 |
| Model Number | 5302-3516 |
| Catalog Number | 5302-3516 |
| Lot Number | V45 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TITAN SPINE |
| Manufacturer Address | 6140 W. EXECUTIVE DR. SUITE A MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |