MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-29 for 110816.09A manufactured by 4web, Inc..
| Report Number | 3009189869-2019-00012 |
| MDR Report Key | 8947545 |
| Date Received | 2019-08-29 |
| Date of Report | 2019-08-29 |
| Date of Event | 2019-07-31 |
| Date Mfgr Received | 2019-08-05 |
| Device Manufacturer Date | 2016-12-17 |
| Date Added to Maude | 2019-08-29 |
| 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. LOGAN FARMER |
| Manufacturer Street | 2801 NETWORK BOULEVARD SUITE 620 |
| Manufacturer City | FRISCO TX 75034 |
| Manufacturer Country | US |
| Manufacturer Postal | 75034 |
| Manufacturer Phone | 8002857090 |
| Manufacturer G1 | 4WEB, INC. |
| Manufacturer Street | 2801 NETWORK BOULEVARD SUITE 620 |
| Manufacturer City | FRISCO TX 75034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT |
| Product Code | PLF |
| Date Received | 2019-08-29 |
| Model Number | 110816.09A |
| Catalog Number | 110816.09A |
| Lot Number | 51219161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 4WEB, INC. |
| Manufacturer Address | 2801 NETWORK BOULEVARD SUITE 620 FRISCO TX 75034 US 75034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-29 |