MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-25 for COMPLETE CERVICAL STAND ALONE IBD 27-40-0130 manufactured by Seaspine Inc..
| Report Number | 3012120772-2020-00012 |
| MDR Report Key | 9750929 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-25 |
| 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 | AUDREY MUDDERMAN |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2165137 |
| Manufacturer G1 | SEASPINE INC. |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPLETE CERVICAL STAND ALONE IBD |
| Generic Name | DRIVER - STRAIGHT |
| Product Code | ODP |
| Date Received | 2020-02-25 |
| Model Number | 27-40-0130 |
| Catalog Number | 27-40-0130 |
| Lot Number | W19985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEASPINE INC. |
| Manufacturer Address | 5770 ARMADA DRIVE CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |