MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-21 for VERTECOR MIDLINE OSTEOTOME 3.0 2003 manufactured by Dfine Inc..
[16086244]
Vertecor midline osteotome was used in multiple vertebrae with sclerotic (dense) bone. Upon use in multiple vertebrae, the outer tube of the device separated form the shaft. The separated section of the device was retrieved without any adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[16287230]
A review of the device history record did not reveal any anomaly related to the complaint. Prior to release of the lot, mechanical test was performed and test results for the lot met all specifications. The vertecor midline osteotome was used in more than one vertebra and in dense bone. Device labeling warns against use of the device in more than one vertebra or dense bone.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2013-00007 |
| MDR Report Key | 3566381 |
| Report Source | 07 |
| Date Received | 2013-11-21 |
| Date of Report | 2013-11-21 |
| Date of Event | 2013-10-24 |
| Date Mfgr Received | 2013-10-30 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-03-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECOR MIDLINE OSTEOTOME 3.0 |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2013-11-21 |
| Returned To Mfg | 2013-11-06 |
| Model Number | 2003 |
| Catalog Number | 2003 |
| Lot Number | 130913A01 |
| ID Number | NA |
| Device Expiration Date | 2014-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-11-21 |