MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-10 for VALEO OL/PL SPINE FUSION 91.004.3710 manufactured by Amedica.
[4259773]
A medica box chisel sets for valeo ol/pl spine fusion designed with small interior ridges that make adequate clearing very difficult and questionable. Item found with bone debris intraoperatively. Took multiple attempts, under high magnification to adequately clean bone fragments. Design reflected in all chisels in this series.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034917 |
| MDR Report Key | 3677447 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-03-05 |
| Date Added to Maude | 2014-03-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALEO OL/PL SPINE FUSION |
| Generic Name | BONE CHISEL |
| Product Code | EML |
| Date Received | 2014-03-10 |
| Model Number | 91.004.3710 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMEDICA |
| Manufacturer Address | SALT LAKE CITY UT 84119 US 84119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-10 |