MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for OMNIPORE CUSTOMIZED SURGICAL IMPLANT OP89021 manufactured by Matrix Surgical Usa.
| Report Number | 3009383407-2020-00002 |
| MDR Report Key | 9884289 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DARREN TROUTMAN |
| Manufacturer Street | 4025 WELCOME ALL RD. STE# 120 |
| Manufacturer City | ATLANTA, GA |
| Manufacturer Country | US |
| Manufacturer Phone | 3440283 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPORE CUSTOMIZED SURGICAL IMPLANT |
| Generic Name | FACIAL IMPLANT; MALAR |
| Product Code | LZK |
| Date Received | 2020-03-26 |
| Model Number | OP89021 |
| Lot Number | 004011218 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATRIX SURGICAL USA |
| Manufacturer Address | 4025 WELCOME ALL RD. STE# 120 ATLANTA, GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-26 |