MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for REFORM POCT SYSTEM 55-IN-0110 manufactured by Precision Spine, Inc..
| Report Number | 3005739886-2020-00013 |
| MDR Report Key | 9898115 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE DAWSON |
| Manufacturer Street | 2050 EXECUTIVE DR |
| Manufacturer City | PEARL MS 39208 |
| Manufacturer Country | US |
| Manufacturer Postal | 39208 |
| Manufacturer Phone | 6014204244 |
| Manufacturer G1 | PRECISION SPINE, INC. |
| Manufacturer Street | 2050 EXECUTIVE DR |
| Manufacturer City | PEARL MS 39208 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 39208 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFORM POCT SYSTEM |
| Generic Name | ROD PUSHER |
| Product Code | LXH |
| Date Received | 2020-03-30 |
| Model Number | 55-IN-0110 |
| Catalog Number | 55-IN-0110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION SPINE, INC. |
| Manufacturer Address | 2050 EXECUTIVE DR PEARL MS 39208 US 39208 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |