MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for MILLENNIUM 85-2481559 manufactured by Avalign Technologies, Inc..
[110600196]
Patient Sequence No: 1, Text Type: N, H10
[110600197]
A screw from the kerrison #3 fell out on the surgical field. The screw and the two separate portions of the instrument were removed from the surgical field and an x-ray of the surgical site was taken and read as clear by radiologist per policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7586219 |
| MDR Report Key | 7586219 |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-05-03 |
| Report Date | 2018-06-01 |
| Date Reported to FDA | 2018-06-01 |
| Date Reported to Mfgr | 2018-06-01 |
| Date Added to Maude | 2018-06-11 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLENNIUM |
| Generic Name | RONGEUR, MANUAL |
| Product Code | HAE |
| Date Received | 2018-06-11 |
| Model Number | 85-2481559 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVALIGN TECHNOLOGIES, INC. |
| Manufacturer Address | 8727 CLINTON PARK DRIVE FORT WAYNE IN 46825 US 46825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-11 |