MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-14 for #3 RHOTON MICROINSTRUMENT manufactured by V Mueller Company.
[1229196]
During a c5-6 anterior cervical decompression and fusion, the tip of #3 rhoton microinstrument tip broke off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012723 |
| MDR Report Key | 1474464 |
| Date Received | 2009-09-14 |
| Date of Report | 2009-09-14 |
| Date of Event | 2009-05-01 |
| Date Added to Maude | 2009-09-22 |
| 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 | 0 |
| 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 | #3 RHOTON MICROINSTRUMENT |
| Generic Name | NONE |
| Product Code | GZX |
| Date Received | 2009-09-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | V MUELLER COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-14 |