MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for STAXX XD 11-1591 manufactured by Spine Wave, Inc..
| Report Number | 3004638600-2019-00011 |
| MDR Report Key | 9182776 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-13 |
| Date Added to Maude | 2019-10-11 |
| 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 | MR. RONALD SMITH |
| Manufacturer Street | 3 ENTERPRISE DRIVE SUITE 210 |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Phone | 2039449494 |
| Manufacturer G1 | SPINE WAVE, INC. |
| Manufacturer Street | 3 ENTERPRISE DRIVE SUITE 210 |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06484 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STAXX XD |
| Generic Name | INTERVERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2019-10-11 |
| Returned To Mfg | 2019-09-20 |
| Catalog Number | 11-1591 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINE WAVE, INC. |
| Manufacturer Address | 3 ENTERPRISE DRIVE SUITE 210 SHELTON CT 06484 US 06484 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-11 |