MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-06 for VERTECOR MIDLINE OSTEOTOME 3.0 3353 manufactured by Dfine Inc..
[4403012]
Based on info received from the dfine international sales representative, a vertecor midline osteotome was used to create channels in six vertebrae. When the physician attempted to remove the device from the last vertebra, the distal tip of the device broke and remained within the vertebral body. The physician was able to complete ablation of the vertebral tumors with a spinestar ablation instrument without complication. The sales representative spoke with the physician via telephone and confirmed that the pt was in recovery and was stable.
Patient Sequence No: 1, Text Type: D, B5
[11896933]
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 and test results for the lot met all specifications. A review of the product specification confirmed that the tip of the device is made from implant grade 316 stainless steel which is a common component of orthopedic implants. The device's instructions for use warns against use in more than one vertebra. However, the device was used in six vertebrae. Regardless of this, no definitive conclusion can be made regarding the reason for failure as the device was not returned for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2014-00001 |
| MDR Report Key | 3829775 |
| Report Source | 07 |
| Date Received | 2014-05-06 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-04-07 |
| Date Mfgr Received | 2014-04-07 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-06-27 |
| 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 Contact | ROBERT FOUNDS |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4087701170 |
| 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 | 2014-05-06 |
| Model Number | 3353 |
| Catalog Number | 3353 |
| Lot Number | 131211A01 |
| Device Expiration Date | 2014-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INC. |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-06 |