MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-23 for SPOTLIGHT * manufactured by Depuy Spine, Inc..
| Report Number | 4486595 |
| MDR Report Key | 4486595 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-23 |
| Date of Event | 2014-12-05 |
| Report Date | 2014-12-23 |
| Date Reported to FDA | 2014-12-23 |
| Date Reported to Mfgr | 2015-02-05 |
| Date Added to Maude | 2015-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPOTLIGHT |
| Generic Name | RETRACTOR |
| Product Code | GZT |
| Date Received | 2014-12-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-23 |