MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-07 for OPTIMESH 330-2505 manufactured by Spineology, Inc..
| Report Number | 2135156-2019-00008 |
| MDR Report Key | 9292875 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-07 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-10-10 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2019-11-07 |
| 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 | ANDREW ADAMS |
| Manufacturer Street | 7800 3RD STREET N. SUITE 600 |
| Manufacturer City | SAINT PAUL MN 551285455 |
| Manufacturer Country | US |
| Manufacturer Postal | 551285455 |
| Manufacturer Phone | 6512568500 |
| Manufacturer G1 | SPINEOLOGY, INC. |
| Manufacturer Street | 7800 3RD STREET N. SUITE 600 |
| Manufacturer City | SAINT PAUL MN 551285455 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551285455 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIMESH |
| Generic Name | MESH, GRAFT CONTAINMENT |
| Product Code | EZX |
| Date Received | 2019-11-07 |
| Catalog Number | 330-2505 |
| Lot Number | S81053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY, INC. |
| Manufacturer Address | 7800 3RD STREET N. SUITE 600 SAINT PAUL MN 551285455 US 551285455 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-07 |