MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-22 for STABILIT FIRST FRACTURE KIT MS4423 manufactured by Dfine, Inc..
[37147625]
Osteotome of the stabilit dfine kit fractured in t12 vertebral body during elective kyphoplasty procedure. Pt was (b)(6) female, known metastatic bone disease from cancer, with t12 metastasis and compression fracture. Due to pain from compression fracture, the pt's physicians recommended, and pt consented to, a kyphoplasty procedure. The procedure was done with the stabilit first fracture kit. The first step is to create a cavity into the bone with the osteotome. The osteotome was introduced, and very hard (sclerotic) bone was encountered. When the device was removed, the physician realized that the tip of the osteotome had fractured, with the tip remaining in the t12 vertebral body. The entire metal fragment was retained within the bone, and the providers judged that the best course of action was to leave it in place. There did not appear to be any adverse clinical consequence to the pt (e. G. , pain, bleeding, or infection risk) due to the retained fragment of the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059766 |
| MDR Report Key | 5398055 |
| Date Received | 2016-01-22 |
| Date of Report | 2016-01-22 |
| Date of Event | 2015-04-22 |
| Date Added to Maude | 2016-01-29 |
| 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 | 3 |
| Brand Name | STABILIT FIRST FRACTURE KIT |
| Generic Name | STABILIT FIRST FRACTURE KIT |
| Product Code | GFI |
| Date Received | 2016-01-22 |
| Model Number | MS4423 |
| Lot Number | 150325A02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE, INC. |
| Manufacturer Address | SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-22 |