MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-21 for SHORELINE ACS ANTERIOR CERVICAL STANDALONE SYSTEM manufactured by Seaspine Inc..
| Report Number | 3012120772-2020-00009 |
| MDR Report Key | 9740682 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-04 |
| Date Added to Maude | 2020-02-21 |
| 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 | SHORELINE ACS ANTERIOR CERVICAL STANDALONE SYSTEM |
| Generic Name | UNKNOWN SHORELINE SCREW |
| Product Code | OVE |
| Date Received | 2020-02-21 |
| 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 | 1. Required No Informationntervention | 2020-02-21 |