MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-03 for XENON LUMBAR SPINAL FIXATION SYSTEM 22SPT10 manufactured by Alphatec Spine Inc.
| Report Number | 2027467-2020-00016 |
| MDR Report Key | 9780321 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-10-14 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2013-02-14 |
| Date Added to Maude | 2020-03-03 |
| 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. RICHARD YOUNGER |
| Manufacturer Street | 5818 EL CAMINO REAL |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4949286 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENON LUMBAR SPINAL FIXATION SYSTEM |
| Generic Name | HXB |
| Product Code | HXB |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 22SPT10 |
| Catalog Number | 22SPT10 |
| Lot Number | 6864602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPHATEC SPINE INC |
| Manufacturer Address | 5818 EL CAMINO REAL CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |