MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-04-10 for CAMBRIA NM 39-2609-S manufactured by Seaspine Inc..
| Report Number | 3012120772-2019-00011 |
| MDR Report Key | 8501607 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-03-15 |
| Date Added to Maude | 2019-04-10 |
| 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 | AARON |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAMBRIA NM |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2019-04-10 |
| Returned To Mfg | 2019-04-02 |
| Model Number | 39-2609-S |
| Lot Number | AU19547605D |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEASPINE INC. |
| Manufacturer Address | 5770 ARMADA DRIVE CALSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |