MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-23 for VERTECOR MIDLINE CEMENT STAGING OSTEOTOME 0987 manufactured by Dfine Inc..
[17869492]
Midline osteotome broke in the third level during a 3 level case.
Patient Sequence No: 1, Text Type: D, B5
[17909919]
The midline osteotome is designed and labeled for use in a single vertebra and the ifu warns against use in dense bone. This midline osteotome was used in three vertebrae during the procedure. Pt's bone was very dense and sclerotic. The articulating tip of the midline osteotome broke in the third vertebra. The physician was able to remove the entire broken articulating tip. No device remained in the pt's body. A review of the device history record did not reveal any anomaly related to the complaint. Prior to release of the lot, mechanical testing was performed. Results of mechanical tests for this lot of midline osteotome met all specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2009-00005 |
| MDR Report Key | 1567960 |
| Report Source | 05 |
| Date Received | 2009-12-23 |
| Date of Report | 2009-12-23 |
| Date of Event | 2009-11-27 |
| Date Mfgr Received | 2009-11-27 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2010-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4083219999 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLINE CEMENT STAGING OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2009-12-23 |
| Returned To Mfg | 2009-12-07 |
| Model Number | 0987 |
| Catalog Number | 0987 |
| Lot Number | CSM-0907-20 |
| Device Expiration Date | 2010-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INC. |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-23 |