MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-11 for 111117.07A manufactured by 4web, Inc..
[141646964]
Subject of this filing was uniquely designed for this patient's specific pathology by the prescribing physician.
Patient Sequence No: 1, Text Type: N, H10
[141646965]
It was reported that the patient presented with pain due to the implant fracturing which led to revision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009189869-2019-00009 |
| MDR Report Key | 8504307 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-11 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2018-02-19 |
| Date Added to Maude | 2019-04-11 |
| 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 | 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 | 3 |
| Generic Name | PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT |
| Product Code | EZX |
| Date Received | 2019-04-11 |
| Model Number | 111117.07A |
| Catalog Number | 111117.07A |
| Lot Number | 40206181 |
| 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 | 2019-04-11 |