MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-21 for JARIT R1840.3 manufactured by Jarit.
[986604]
While placing an intravertebral implant, it became lodged and needed to be moved. The physician attempted to move the implant with the blakesley pituitary rongeur. The upper jaw of the blakesley pituitary rongeur broke off in the wound and could not be retrieved. The broken piece was left in the pt per physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009057 |
| MDR Report Key | 1245767 |
| Date Received | 2008-11-21 |
| Date of Report | 2008-11-21 |
| Date of Event | 2008-11-20 |
| Date Added to Maude | 2008-12-04 |
| 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 | JARIT |
| Generic Name | RUGGLES PITUITARY RONGEUR |
| Product Code | EMH |
| Date Received | 2008-11-21 |
| Catalog Number | R1840.3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1302806 |
| Manufacturer | JARIT |
| Manufacturer Address | 9 SKYLINE DRIVE HAWTHORNE NY 10532 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-11-21 |