MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-26 for MEDTRONIC MICRO PITUITARY RONGEUR 9569567C manufactured by Medtronic Sofamor Danek Usa, Inc..
[155977560]
Retained foreign object. During an open left l4-5 and l5-s1 hemilaminectomy, medial facetectomy and microdiscectomy, the medtronic micro pituitary rongeur (black, size 2mm, prod #9569567c) broke inside the pt. One of the "jaws" broke off in the l5-s1 disc space. Attempts were made to retrieve it but were unsuccessful. The determination was to leave it in as more attempts would likely cause more harm than benefit. The instrument was sequestered and we have it available for inspection. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5089351 |
| MDR Report Key | 8935806 |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-08-21 |
| Date Added to Maude | 2019-08-27 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDTRONIC MICRO PITUITARY RONGEUR |
| Generic Name | RONGEUR |
| Product Code | HTX |
| Date Received | 2019-08-26 |
| Model Number | 9569567C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-26 |