MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-13 for JARIT 230-261 * manufactured by Integra Lifesciences Corporation.
[4003894]
During posterior spinal surgery a leksel rongeur broke. All pieces were retrieved. Flat plate x-ray taken during closure and read as negative for foreign bodies by radiologist prior to completion of closure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3483021 |
| MDR Report Key | 3483021 |
| Date Received | 2013-11-13 |
| Date of Report | 2013-11-13 |
| Date of Event | 2013-10-24 |
| Report Date | 2013-11-13 |
| Date Reported to FDA | 2013-11-13 |
| Date Reported to Mfgr | 2013-11-22 |
| Date Added to Maude | 2013-11-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT |
| Generic Name | RONGEUR |
| Product Code | EMH |
| Date Received | 2013-11-13 |
| Model Number | 230-261 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 311 ENTERPRISE DR PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-13 |