MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-26 for ASTRA SPINE SYSTEM A5RR-Z55-300 manufactured by Spinecraft.
| Report Number | 3004717358-2020-00001 |
| MDR Report Key | 9886956 |
| Report Source | OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2016-05-23 |
| Date Added to Maude | 2020-03-26 |
| 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 | MS. AMI AKALLAL-ASAAD |
| Manufacturer Street | 777 OAKMONT LANE, SUITE # 200 |
| Manufacturer City | WESTMONT, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 9207300233 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTRA SPINE SYSTEM |
| Generic Name | ROD |
| Product Code | NKB |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-24 |
| Catalog Number | A5RR-Z55-300 |
| Lot Number | 112980 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINECRAFT |
| Manufacturer Address | 777 OAKMONT LANE, SUITE # 200 WESTMONT, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |