MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-19 for SKYLINE CAM LOCKING * manufactured by Depuy Spine.
[2247989]
Cam lock tightener of the depuy skyline plating system broke while in use. All pieces were accounted for.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2303795 |
| MDR Report Key | 2303795 |
| Date Received | 2011-10-19 |
| Date of Report | 2011-10-19 |
| Date of Event | 2011-10-13 |
| Report Date | 2011-10-19 |
| Date Reported to FDA | 2011-10-19 |
| Date Added to Maude | 2011-10-21 |
| 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 | 0 |
| 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 | SKYLINE CAM LOCKING |
| Generic Name | CAM LOCK TIGHTENER |
| Product Code | LRZ |
| Date Received | 2011-10-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-19 |