MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-06 for PEDICLE SCREW manufactured by Amendia.
[4457201]
Pedicle screw broke while placing with amendia counter torque in conjunction with final tightening screwdriver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036536 |
| MDR Report Key | 3870182 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-06-05 |
| Date of Event | 2014-05-28 |
| Date Added to Maude | 2014-06-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PEDICLE SCREW |
| Generic Name | NONE |
| Product Code | MCV |
| Date Received | 2014-06-06 |
| Lot Number | A103547 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMENDIA |
| Manufacturer Address | MARIETTA GA 30062 US 30062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-06 |